Neoplasms

All Conditions

Head and Neck Neoplasms

Patients will receive the symbiotic product LactoFos twice a day during seven days after surgical treatment. The intervention consists of giving twice a day a sachet of 6g of symbiotic diluted in 20mL of water via nasoenteric tube for seven days, totaling the administration of 14 sachets per intervention.

Patients will receive 6g of maltodextrin twice a day during seven days after surgical treatment.

Intervention will consist of the adminitration of symbiotic product twice a day during seven days after surgical treatment

Symbiotic

Intervention will consist of the adminitration of placebo product twice a day during seven days after surgical treatment

Maltodextrin

Priscilla C Lages, bachelor

The purpose of this study is to determine whether the symbiotic use in patients with head and neck cancer impact on intestinal function after surgical treatment.

The study will be conducted offering the patients symbiotic product twice a day for seven days after the surgical treatment. Patients will be monitored for the number of stools, stools consistency, abdominal pain and gas overproduction.

Impact of Symbiotic Administration on Intestinal Function of Head and Neck Patients Surgically Treated

Intestinal Function of Patients With Uper Air and Digestive Neoplasia Submitted to Surgical Treatment: Symbiotic Use Impact

The intestinal permeability using serum DAO enzyme concentration (ng/mL) was determined by sandwich enzyme-linked immunosorbent assay (ELISA) kit (SEA656Hu), according to Cloud-Clone Corporation® (Huston, TX) specifications.

Federal University of Minas Gerais

Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days.

Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days.

Total

Age, Categorical

Sex: Female, Male

Nourished

Malnourished

Nutritional status

Dr. Maria Isabel Correia

Serum DAO Enzyme Concentration

Infection Rate

Patients will receive twice a day the symbiotic product during seven days after surgical treatment

LactoFos: Patients will receive the product twice a day during seven days after surgical treatment

Patients will receive twice a day the placebo product during seven days after surgical treatment

Maltodextrin: Patients will receive maltodextrin twice a day during seven days after surgical treatment

Overall Study

Infections

Symptoms and General Pathology

Wounds and Injuries

Blood and Lymph Conditions

Behaviors and Mental Disorders

Rare Diseases

Communicable Diseases

Hyperthermia

Neutropenia

Fever

Febrile Neutropenia

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Granulocytopenia

Other Dietary Supplements

All Drugs and Chemicals

Acidophilus

Inulin

Bifidobacterium

Interventions: administration of Probio-Fix Inum + Beneo Synergy 1

Start of prophylaxis: 5 days before or 2 days after starting chemotherapy

Prophylaxis duration: 3 months

Interventions: administration of placebo

Start: 5 days before or 2 days after starting chemotherapy

Duration: 3 months

Dose of Probio-Fix Inum: 1 capsule daily first 14 days + 1 capsule twice daily for the rest of prophylaxis duration

Probio-Fix Inum: each capsule contains 2.7 billion lyophilized probiotic bacteria Lactobacillus rhamnosus GG, LGG, American Type Culture Collection (ATCC) 53103 and Bifidobacterium animalis subspecies. lactis BB-12 Chr. Hansen Beneo Synergy 1: oligofructose-enriched inulin

Probio-Fix Inum

Dose of Beneo Synergy 1: depends on the age of the patient (full dose variation: 0,2g/100ml milk formula - 12g/daily), gradually increased as tolerated by the patient every 2-3 days in first 8-12 days

Beneo Synergy 1

Placebo

Vladimir Holec, MD, PhD

Michal Mego, MD, PhD

Pavel Bician, MD

Vladimir Zajac, RNDr

Febrile neutropenia (FN) is a major life-threatening treatment complication in cancer patients undergoing intensive chemotherapy. Endogenous flora is considered to be one of the main sources of infections during neutropenia. Competitive inhibition of gut mucosal colonization by pathogenic microorganisms using synbiotics could represent one of the potential options for its prevention. Synbiotics represent combination of two components: probiotics and prebiotics. Probiotics are live microorganisms, which in form of drugs or food supplements administered at a sufficient dose help to maintain health beneficial microbial balance in the digestive tract of a human or other host. Prebiotics are food ingredients nondigestible for our digestive enzymes, but can be fermented by bacteria in our bowel and this way selectively stimulate growth or activity of specific saccharolytic bacterial strains. These changes in composition of our microflora may bring benefits on host well-being and health. Based on the results of human and animal studies, probiotics probably can not only decrease the level of gut colonisation with pathogenic bacteria, but may also lead to reduction in the duration of neutropenia, accelerate the restitution of the intestinal mucosa and boost immunity. Despite a significant number of studies on probiotics still only little evidence of their safety especially in immunocompromised patients is available.

To help find new options for increasing quality of healthcare for children cancer patients and also to evaluate safety of this new approach investigators designed double-blinded placebo controled multicenter study aimed to decrease the number of febrile episodes using prevention with synbiotic.

Febrile neutropenia (FN) is a major complication in cancer patients undergoing intensive chemotherapy. Endogenous flora is considered to be one of the main sources of infections in neutropenic patients. The first step in infection process is colonization of the intestine by pathogenic bacteria with their subsequent translocation through the intestinal mucosa and systemic dissemination.

The alterations of the intestinal flora occurs due to chemotherapy and also due to the use of broad spectrum antibiotics, which suppresses anaerobic growth of the normal gut flora leading to a damage of colonization resistance. Competitive inhibition of gut mucosal colonization by pathogenic micro-organisms using synbiotics could represent one of the potential options for the prevention of febrile neutropenia in cancer patients. Compared with the existing selective bowel decontamination with quinolones and/or trimethoprim-sulfamethoxazole, investigators may expect also reduction of the incidence of fungal and Gram-positive infections due to changes in the intestinal microflora. Based on the results of animal studies, probiotics could probably also lead to a reduction in the duration of neutropenia and boost immunity.

Synbiotics represent combination of two components: probiotics and prebiotics. Probiotics are live microorganisms, which in form of drugs or food supplements administered at a sufficient dose help to maintain health beneficial microbial balance in the digestive tract of a human or other host. Prebiotics are food ingredients nondigestible for our digestive enzymes, but can be fermented by bacteria in our bowel and this way selectively stimulate growth or activity of specific saccharolytic bacterial strains.

Lactic acid bacteria are currently widely used in prevention and treatment of certain infectious diseases. They stimulate the immune system, compete for substrate with pathogenic bacteria, produce bacteriocins, competitively inhibit bacterial adhesion sites, increase the transepithelial resistance and bind some mutagens.

Current evidence supporting probiotic use as adjunctive therapy to anticancer treatment is limited, especially in cancer patients treated with chemotherapy. Some of the reports support their beneficial effects on certain aspects of toxicity related to chemotherapy and radiation therapy; however, large properly designed clinical trials are needed to assess their real position as a part of anticancer treatment.

Eleven studies in cancer patients were included in meta-analysis to assess efficacy of probiotics. Results show that probiotics may reduce the severity and frequency of diarrhoea in patients with cancer and may reduce the requirement for anti-diarrhoeal medication, but still more studies are needed to assess the true effect. The importance of probiotics in the treatment of acute diarrhea is supported by meta-analysis of 34 randomized placebo-controlled studies, which showed significant reduction in diarrhea incidence with better effect especially in the pediatric group. Most of these studies were performed with the probiotic strain Lactobacillus rhamnosus GG (LGG). The duration of rotavirus diarrhea in children and diarrhea in immunocompromised HIV-positive patients was significantly shortened after administration of certain strains of Lactobacilli resp. Saccharomyces boulardii.

Investigators can find only anecdotal reports about use of probiotics in patients with neutropenia. In experimental models with cyclophosphamide-treated mice preventive treatment with immunomodulatory lactobacilli was successfully used to protect against myelosuppression and immunosuppression. Lactobacilli were able to induce an early recovery of neutrophils in blood, improve phagocytic cells recruitment to infectious sites and increase the resistance against the opportunistic pathogen C. albicans. In another similar study administration of heat-inactivated strain of Enterococcus faecalis shortened the duration of cyclophosphamide-induced neutropenia and speeded up the restitution of neutrophil count. The important feature of the lactic acid bacteria is ability to produce fatty acids with short chain, which is an important metabolite for colonocytes and this way they may participate in the faster restitution of the mucosa after chemotherapy.

Probiotics fall into the category of organisms classified as "generally regarded as safe". The safety concerns with probiotic administration in cancer patients are related mainly to risk of infection caused by probiotic bacteria and transfer of antibiotics resistance.

Many probiotics strains are naturally resistant to antibiotics, but majority of this resistance is intrinsic (chromosomally encoded) and therefore nontransmissible. This could be a danger, when probiotics become infectious agents, on the other hand probiotic strains with intrinsically antibiotic-resistance may benefit patients, whose normal intestinal microflora has become greatly reduced or unbalanced due to the administration of various antimicrobial agents. For some strains (e.g. LGG) the plasmid-free status was proven, but at the same time it was shown, that some strains may carry potentially transmissible plasmid-encoded antibiotic resistance genes, which could lead to the formation of new antibiotic-resistant pathogens. Therefore, one of the key requirement for probiotic strains is that they should not carry transmissible antibiotic resistance genes.

Despite the fact, that the incidence of infections caused by lactic acid bacteria is extremely low, there exists certain risk, that they can become pathogenic. In case reports probiotics are mentioned as causing local infections such as chest infections, digestive tract infections, urinary tract infections, and meningitis. Though reported lactobacilli bacteremia are very unusual and rare in the pediatric population. They were naturally more often observed in immunocompromised patients, such as in patients with bone marrow transplantation or in patients with AIDS, which also demonstrates low-virulency of these strains. Moreover, clinical isolates of L. rhamnosus captured in these cases had some significant phenotypical differences in one or more properties associated with virulence compared to those, which are used as probiotic strains. Concerns of iatrogenic infection are one of the main reasons for limited experience with administration of probiotics in granulocytopenic patients. In addition, due to chemotherapy it comes not only to neutropenia but also to local affection of gut mucosa and therefore hypothetically arise the possibility of bacterial translocation. This phenomenon is caused by a defective intestinal barrier, immunosuppression and also gut prematurity. It was described as the passage of viable indigenous bacteria from the gastrointestinal tract to extraintestinal sites and may result in the transfer of bacteria to other organs, thereby potentially causing bacteremia, septicemia, and multiple organ failure. However, evidence from animal model studies suggests that there is actually a reduction in the translocation of other bacteria when probiotics are given, as opposed to the transmigration of probiotic bacteria into the bloodstream.

The concerns around bacteraemia/fungaemia or blood culture growth are significant in cancer patients, but this risk needs to be considered alongside any potential benefit. Systematic review including 17 studies with cancer patients identified only five such case reports of the 756 cases described consuming probiotics. Moreover such cases were noted also in patients not known to be consuming probiotics. In addition, there is no evidence from population based studies of any increased risk of bacteremia or endocarditis due to probiotics and their incidence still remained extremely low despite current widespread use of probiotic. Even findings of some small studies in groups of specific immunocompromised patients (e.g., patients with HIV infection) support the safety of particular probiotic strains.

One of the most recent systematic reviews identified 11,977 publications, of which 622 studies (included 24,615 participants using a probiotics) were included in the review. Based on reported adverse events, randomized controlled trials showed no statistically significantly increased relative risk of the over all number of experienced adverse events (Relative risk (RR) = 1.00; 95% Confidence interval (CI): 0.93, 1.07, p = 0.999); gastrointestinal; infections; or other adverse events, including serious adverse events (RR = 1.06; 95% CI: 0.97, 1.16; p = 0.201), associated with short-term probiotic use compared to control group participants; long-term effects are largely unknown. Case studies suggested that participants with compromised health are most likely to experience adverse events associated with probiotics. However, randomized control trials (RCTs) in medium-risk and critically ill participants did not report a statistically significantly increased risk of adverse events compared to control group participants. In conclusion authors of this analysis state, that the available evidence in RCTs does not indicate an increased risk; however, rare adverse events are difficult to assess. However, despite the substantial number of publications, the current literature is not well equipped to answer questions on the safety of probiotic interventions with confidence, especially in group of critically ill patients. Nevertheless, in specific probiotics group, as lactobacilli and bifidobacteria, some authors report that current evidence suggests, that the risk of infection with these probiotic groups is similar to that of infection with commensal strains and though consumption of such products presents a negligible risk to consumers, including immunocompromised hosts. Moreover, this potential risk needs to be always considered alongside any potential benefit. Despite limited data, it seems that probiotic bacteria as live microorganisms could be safely administered even in setting of neutropenia. Future research should focus on selection of most effective and safe probiotic strains and their combinations, and/or administration of probiotics with prebiotics to increase their success in maintaining colonization resistance and in prevention of the adverse events of anticancer treatment.

In a comparable study phase I. probiotic strain was applied to 11 cancer patients to evaluate their benefits and safety. Subsequently, 14 patients with acute myeloid leukemia treated with chemotherapy were enrolled in phase II. None of reported febrile episodes was induced by probiotic strain and no severe adverse events were recorded. Despite limited number of patients, this was the first direct evidence of the safety of probiotics in patients receiving chemotherapy.

One of the causes of failed efficacy of probiotics in the prevention of febrile neutropenia may be the presence of other entries of infection such as central venous catheters. Also, the efficiency of colonization, mucosal damage due to chemotherapy dose and specific probiotic strain may be the causes of this. Another reason may be the inability of one probiotic strain to compensate all changes in the intestinal microflora induced by chemotherapy. One way to solve this problem may be use of combination of multiple probiotic strains. Appropriate selection of strains is required, cause they must not behave antagonistically to each other. Other option is to use combination of prebiotics with probiotics. This can lead not only to acceleration of gut colonization by probiotics, but also to stimulation of endogenous flora growth, which may enhance colonization resistance at another level.

Prevention of Febrile Neutropenia by Synbiotics in Pediatric Cancer Patients

Prevention of Febrile Neutropenia in Pediatric Cancer Patients by Lactobacillus Rhamnosus GG and Bifidobacterium Animalis Subspecies. Lactis BB-12 in Combination With Inulin and Oligofructose

Febrile neutropenia is defined as an oral temperature \>38.3°C or two consecutive readings of \>38.0°C sustained for more than 1 hour and an absolute neutrophil count \<0.5 × 109/l, or expected to fall below 0.5 × 109/l in the next 48-hour period

Safety will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf

S&D Pharma SK s.r.o.

Digestive System Diseases

Surgical Wound Infection

Surgical Wound

Wound Infection

Colorectal Neoplasms

Disease Attributes

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Postoperative Complications

symbiotic group

placebo group

Aline Taborda, ms

Daniel Damin, dr

aline taborda, ms

This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. The researchers will compare incidence of surgical site infection between the study groups.

This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be randomly selected to receive either a symbiotic formulation or placebo during the perioperative period. The researchers will compare incidence of surgical site infection, detected by clinical examination and complementary tests (CT scans, X-rays, microbiological and hematological tests) between the study groups.

Symbiotics to Prevent Postoperative Infection in Colorectal Cancer

Change in Incidence of Surgical Site Infection After Resection of Colorectal Cancer Between Patients Receiving a Symbiotic Compound and Patients Receiving a Placebo.

This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. After we will compare the number of participants with incidence of surgical site infection between the study groups.

Hospital de Clinicas de Porto Alegre

Colonic Neoplasms

Diarrhea

Dysbiosis

Signs and Symptoms, Digestive

Herbal and Botanical

Cola

You will receive 6 grams of the symbiotic (association of fructooligosaccharides, prebiotics, and four probiotic strains: Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus Acidophilus, and Bifidobacterium bifidum) either enterally or twice a day.

Will receive 6 grams of the maltodextrin placebo (carbohydrate easily absorbed and digested, not fermented by colonic bacteria and which does not interfere in the microbial ecology of the gastrointestinal tract or in the metabolism and function of the intestine), either enterally or orally in two sachets times a day

6 grams of the symbiotic will be administered twice a day

Simbyotic

6 grams of the maltodextrin will be administered twice a day

Control Group

Maria Isabel Toulsson Davisson Correia, Doctor

Simone V Generoso

Maria Isabel TD Correia, MD, PhD

Due to the high incidence, cancer and the concomitant presence of malnutrition are currently a worldwide public health problem. The loss of weight and body tissues is a common condition in cancer patients with lesions of the airways and digestive tract and is related to anorexia and the presence and duration of gastrointestinal symptoms, such as diarrhea. The latter directly interferes with the progression of enteral diets, which are administered in order to provide adequate nutritional support for the recovery of patients and nutritional status. In this sense, the importance of measures to help reduce diarrhea episodes is reinforced, aiming at the adequate infusion of enteral diets and, consequently, nutritional needs. It is known that the use of antimicrobials is closely related to the increased incidence of nasocomial diarrhea, as it facilitates colonization by pathogenic bacteria, such as Clostridium difficile. In addition, nosocomial diarrhea is a very relevant occurrence due to the financial burden it causes for the hospital institution, which can also worsen the patient's clinical condition, since he is weakened due to the underlying disease. Despite these important aspects, studies carried out with the aim of reducing diarrhea episodes in patients with airway and digestive lesions are still not described in the literature. In this context, the use of symbiotics presents itself as a possibly beneficial alternative, considering the role of probiotics and prebiotics in the modulation of intestinal function. In this sense, this work aims to evaluate the impact of perioperative supplementation with symbiotic on clinical outcomes and intestinal function of patients with colon cancer and digestive airways undergoing colorectal resection. It is assumed that the use of symbiotics could have better results than the use of probiotics and isolated prebiotics.

Most cancer patients have a compromised nutritional status, 80% are malnourished at the time of the initial diagnosis. It is known that in patients with airway and digestive cancer the risk of malnutrition is increased, due to changes caused by the location of the tumor such as dysphagia, odynophagia and changes in taste.

The clinical effects of malnutrition are manifested by difficulty in healing after surgery, increased risk of infection and treatment toxicity, in addition to greater demand for care and hospital costs. Therefore, it is of utmost importance to provide adequate nutritional needs to these patients, since adequate nutritional therapy (NT) is able to improve their clinical response and prognosis.

Nutritional support is seen as an important strategy for the treatment and recovery of these patients, since it promotes greater adequacy of nutritional support, improving nutritional status as well as response to treatment and immune function, in addition to improving quality of life and reducing hospital costs. However, gastrointestinal complications, such as diarrhea, represent important causes for not receiving the planned enteral diet volume, or the patient's intake inadequacy, which causes an insufficient supply of calories, proteins, vitamins and minerals over the days, contributing with worsening nutritional status, as well as increased hospital stay and costs with hospitalization.

Diarrhea affects about 16% to 63% of patients on enteral nutrition. The most frequent causes of diarrhea in cancer patients are related to medications, such as antibiotics, antacids with magnesium, lactulose, laxatives, supplements with potassium and phosphorus and medications with sorbitol6. Other possible causes of diarrhea include hypoalbuminemia, rapid infusion and intolerance to some component of the diet, infectious causes such as the presence of Clostridium difficile, severe malnutrition and, more rarely with the use of industrialized diets, bacterial contamination of the enteral formula.

In particular, the presence of nosocomial diarrhea - defined as infectious diarrhea acquired in a hospital environment - increases the length of stay of patients (eight days, on average), increases the likelihood of infections in surgical wounds, and consequently, hospital mortality. Among the identifiable causes of this type of diarrhea, the indiscriminate use of antimicrobials has been identified as an important predisposing factor, particularly in facilitating colonization and intestinal infection by Clostridium difficile. This bacterium has an incidence between 5% and 39%, with an increased incidence in hospitalized post-surgical patients.

Thus, it is necessary to study strategies that reduce the incidence of diarrhea in these patients. In this context, the use of probiotics and prebiotics seems to be an effective alternative, since the therapeutic effect in the treatment and prevention of intestinal diseases has been extensively researched.

Probiotics are live microorganisms that, when consumed in adequate and sufficient quantities, confer benefits to the health of the host. In addition, they compete with pathogenic bacteria for space and nutrients, blocking their effects and binding them to the intestinal mucosa. They produce antibacterial substances (bacteriocins), acidify the intestinal pH by fermentation and production of lactic acid, stimulate the production of mucin and increase the production and secretion of immunoglobulin A (sIgA). There is evidence that probiotics also contribute to the reduction of inflammatory mediators such as tumor necrosis factor (TNF) and growth transformation factor (TGF-β) that modulate the inflammatory response and favor immune balance. Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus acidophilus and Bifidobacterium are some of the probiotics that have benefits described in the literature.

Cimperman et al (2011), in a pilot study, double masked, controlled placebo evaluated the effect of treatment with probiotics in patients using antibiotics. The results showed that the administration of the probiotic Lactobacillus reuteri significantly reduced diarrhea compared to patients who received a placebo. Still, D'Souza et al (2002), Cremonini et al (2002) \& McFarland (2006) concluded through meta-analyzes that the use of probiotics is associated with the prevention of diarrhea associated with the use of antibiotics in hospitalized patients.

Prebiotics are defined as food substances that, when ingested, are not digested and absorbed by the small intestine. When they reach the colon, they are used as a substrate for probiotics, selectively stimulating the growth of the intestinal microbiota in addition to producing short-chain fatty acids (SCFA) that are substrates for colonocytes. SCFAs also modulate the intestinal microbiota, maintain metabolism and promote a decrease in intestinal pH, thereby inhibiting the development of pathogenic microorganisms. Rushdi, Pichard \& Khater (2004) evaluated in a prospective, double-masked controlled study the effect of adding soluble fiber to the enteral diet of patients hospitalized with diarrhea. Patients were randomly divided into two groups: control (enteral diet without soluble fiber) and treated (enteral diet with soluble fiber). The results showed a reduction in diarrhea episodes in the study patients, suggesting the prebiotic benefit of soluble fiber. Examples of prebiotics are fructooligosaccharides (FOS) and galactooligosaccharides (GOS).

These findings propose that interventions aimed at modulating intestinal function related to the prevention and control of diarrhea in cancer patients in the postoperative period deserve to be implemented and evaluated. However, these trials used different probiotic organisms, prebiotics, doses, duration of treatment and target audience, providing low reproducibility of the results. In addition, some studies have shown that symbiotics (defined as a combination of probiotics and prebiotics) can optimize the beneficial results in relation to the isolated use of probiotics in terms of modulating the immune system and the intestinal microbiota. It is suggested that under the action of symbiotics there will be better control of intestinal functioning and improved prognosis.

In this sense, evaluating the symbiotic administration in patients with colon, upper airway and digestive cancer undergoing surgical treatment would be a potentially beneficial alternative to be studied, since the consumption of this food component could lead to modulation of intestinal function, preventing diarrhea that, according to our data, occurs in 30% of the patients hospitalized at the Alfa Institute of Gastroenterology at UFMG.

General objective

To evaluate the impact of the symbiotic on the intestinal function of patients with malignant neoplasm of the colon, upper airways and digestive tract submitted to surgical treatment.

Specific objectives

* Assess the incidence of diarrhea in the study group;
* Identify other gastrointestinal symptoms such as stasis, vomiting, bloating;
* Identify and monitor the evolution of the nutritional status of patients through subjective global assessment, anthropometry and food consumption;
* Track postoperative complications, in general.

The study will be carried out at the Alfa Institute of Gastroenterology, Hospital das Clínicas, Federal University of Minas Gerais, located in Belo Horizonte, Minas Gerais.The sample will comprise 42 patients (21 in the intervention group and 21 in the control group). The sample calculation was performed according to Hulley et al. (2001), using the proportion of 30% improvement in the symptom of diarrhea with the use of symbiotic from the average of other studies, considering a range of 45% of the confidence interval (difference between the highest and the lowest value found) and 12% loss with the intervention, also observed in the reference studies. Individuals will be invited to participate in the study and will have a detailed explanation of the procedure and research in which they will be inserted, and must sign a free and informed consent form. Individuals who have inflammatory bowel diseases will be excluded; have previously undergone operations on the gastrointestinal tract; have used antibiotics, prebiotics, probiotics or symbiotics in the last 15 days and are using an enteral fiber diet. The study will be double-masked and the individuals will be randomly divided into two groups: Symbiotic group (S) - will receive the symbiotic (association of fructooligosaccharide, prebiotic, and four probiotic strains: Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus Acidophilus, and Bifidobacterium bifidum) enterally or orally in the amount of a sachet, twice a day. Control Group (C) will receive maltodextrin placebo (carbohydrate easily absorbed and digested, not fermented by colonic bacteria and which does not interfere in the microbial ecology of the gastrointestinal tract or in the metabolism and function of the intestine), either enterally or orally in a sachet. hours until hospital discharge. Personal information such as full name, medical record number, sex, age, marital status, origin, date of birth and hospitalization will be collected for patient identification. Information regarding the location of the tumor, type of tumor, age of diagnosis in years and months, type of previous and current treatment (surgical, radiotherapy and / or chemotherapy) use of antibiotics, comorbidities and presence or not of infection will be collected from the medical record . The evaluation of intestinal functioning will be made by direct questioning to patients and family members, as well as the nursing records. The occurrence or not of diarrhea (defined as more than three bowel movements / day), frequency and volume, whether or not gastrointestinal symptoms such as distension and abdominal pain during hospitalization will be assessed. Nutritional assessment will be carried out by Subjective Global Assessment proposed by Detsky (1987) and using anthropometric parameters: current weight, height, arm, tricipital skin fold, subscapular and biochemical.

The start of the diet in the postoperative period and the nutrient supply will be verified through the analysis of food consumption and / or infusion of the enteral diet, which was calculated according to the service protocol, contemplating 30 calories per kilogram of current weight.

Complications will be assessed through the daily assessment of the patient and medical records and classified according to the proposal by Dindo (2004).

The study will be double-masked and individuals will be randomly divided into two groups: Symbiotic group (S) - will receive the symbiotic (association of fructooligosaccharide, prebiotic, and four probiotic strains: Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus Acidophilus, and Bifidobacterium bifidum) enterally or orally in the amount of a sachet, twice a day. Control Group (C) will receive maltodextrin placebo (carbohydrate easily absorbed and digested, not fermented by colonic bacteria and which does not interfere in the microbial ecology of the gastrointestinal tract or in the metabolism and function of the intestine), either enterally or orally in a sachet. hours until hospital discharge.

All individuals directly involved in the research will be masked. The modules used in the study were masked by an individual external to the research, being the only one who knew the composition.

Effect of the Use of Symbiotics in Patients With Colon Cancer

Intestinal Function of Patients With Colon Neoplasia, Airways and Upper Digestives Subjected to Surgical Treatment: Impact of the Use of Symbiotics

Assess the incidence of diarrhea by collecting information on the frequency and consistency of stools. Stool consistency will be classified using the Bristol scale.

Monitor patients' nutritional status through subjective global assessment, weight, arm circumference, tricipital skinfold and food consumption.

Evaluate operative complications, such as length of hospital stay, need for mechanical ventilation, need for enteral or parenteral nutritional therapy and mortality, through medical records

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Symbiotic Administration on Intestinal Function of Head and Neck Patients Surgically Treated	NCT02654652	Head and Neck C... Synbiotics Nutrition Thera...	Symbiotic Maltodextrin	18 Years -	Federal University of Minas Gerais
Prevention of Febrile Neutropenia by Synbiotics in Pediatric Cancer Patients	NCT02544685	Febrile Neutrop... Neutropenia Infection in an... Cancer	Probio-Fix Inum Beneo Synergy 1 Placebo	6 Months - 19 Years	S&D Pharma SK s.r.o.
Symbiotics to Prevent Postoperative Infection in Colorectal Cancer	NCT02571374	Colorectal Canc... Surgical Site I...	symbiotic group placebo group	18 Years - 85 Years	Hospital de Clinicas de Porto Alegre
Effect of the Use of Symbiotics in Patients With Colon Cancer	NCT04874883	Symbiotic Cancer Colorect... Cancer Head Nec... Intestinal Dysb... Diarrhea Intestinal Micr... Nutritional Sta...	Simbyotic Control Group	18 Years -	Federal University of Minas Gerais

Spots Global Cancer Trial Database for symbiotic

Every month we try and update this database with for symbiotic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for symbiotic

Every month we try and update this database with for symbiotic cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for symbiotic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.