Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Disease Attributes

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

In the enrollment, women who have undergone cervical cytology (TCT) examination for the last 3 months with abnormal results will be included in this study. All participants will be followed up three times, at 6 months, 12 months and 24 months.

Participants will be followed up at 6, 12 and 24 months with the test of enous blood, vaginal secretions, faeces, and cervical exfoliated cells.

Follow up

Pengming Sun, PhD.

There are different microbial communities on the surface of human body (skin, hair, nails, etc.) and in the cavity connected with the outside world. The human microbiota is the general term of the genetic information of microorganisms that coexist with human beings and cause various diseases under certain conditions. The results of human microbial genome analysis show that the microbial communities in different parts of the human body and different individuals have amazing diversity, some of which play an important role in human health, and some are closely related to diseases. Female lower genital tract infection is often associated with human papillomavirus (HPV) infection and bacterial vaginosis (BV), such as cervical and vaginal precancerous lesions, cancer, condyloma acuminatum and other sexually transmitted diseases (STD). Persistent infection of high-risk human papillomavirus (HR-HPV) is closely related to the occurrence of invasive cervical cancer. New evidence suggests that vaginal microbiota composition is different in women with HR-HPV infection and high-grade cervical lesions. The increase of the severity of cervical intraepithelial neoplasia is related to the decrease of the relative abundance of vaginal Lactobacillus. In addition to vaginal microbes, the powerful intestinal flora is considered to be the "invisible organ" of the human body. There is a dynamic and balanced interaction network between intestinal microorganisms and human immune cells. Once the intestinal flora is out of balance, the changes in species, quantity, proportion, location and biological characteristics will cause a series of inflammatory reactions and immune system diseases, and even lead to cancer. Some studies have shown that there is a potential relationship between intestinal microorganisms and vaginal microorganisms. Recent research evidence suggests that the mutually beneficial relationship between oral bacteria and other vaginal bacteria supports the colonization of pathogens and may help maintain the characteristics of vaginal flora imbalance.

Based on the clinical practice, this study carried out a multi center cohort study in Fujian Province, China. In this study, five research including Fujian Maternity and Child Health Hospital, Mindong Hospital of Ningde City, Zhangzhou affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Afflicated to Fujian Medical University and Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University were included, each of which included 600 individuals, with a total of 3000 women with potential cervical lesions were enrolled. Blood samples were tested for immunology, stool swabs and vaginal secretions were collected for microecological evaluation. At the same time, 21 kinds of common HPV virus types, cervical exfoliative cytology and 10 kinds of common STDs pathogens were detected. The included population will be tested with the same samples at 6, 12 and 24 months of follow-up to explore the relationship between vaginal, intestinal microorganisms and cervical HPV infection and the development of cervical lesions and its potential impact, so as to further explore the key factors affecting the persistent infection and clearance of HPV in female reproductive tract and the potential impact factors of the occurrence and development of cervical lesions. This prospective observational the characteristics of vaginal and intestinal microbiota in women with different cervical HPV infection, to evaluate the relationship and the underlying effect in the developoing of cervical lessions.

DNA specimens of exfoliated cervix cells；DNA samples of vaginal secretions.

Characteristics of Vaginal and Intestinal Microbiota and Cervical HPV Infection

Characteristics of Vaginal and Intestinal Microbiota in Women With Different Cervical HPV Infection

Cervical histopathology was performed at baseline for all participants.

Cervical histopathology was performed at 12-month follow-up for cervical HPV infection or cytology abnormalities women.

Cervical histopathology was performed at 24-month follow-up for cervical HPV infection or cytology abnormalities women.

All participants were tested for HPV DNA of cervical exfoliated cells at the time of baseline.

All participants were tested for HPV DNA of cervical exfoliated cells at the time of 6-month follow-up.

All participants were tested for HPV DNA of cervical exfoliated cells at the time of 12-month follow-up.

All participants were tested for HPV DNA of cervical exfoliated cells at the time of 24-month follow-up.

All participants were tested for cervical cytology at the time of baseline.

All participants underwent microbiological metagenomic sequencing of vaginal secretions at baseline.

All participants underwent microbiological metagenomic sequencing of vaginal secretions at 6-month follow-up.

All participants underwent microbiological metagenomic sequencing of vaginal secretions at 12-month follow-up.

All participants underwent microbiological metagenomic sequencing of vaginal secretions at 24-month follow-up.

All participants underwent fecal microbiome sequencing at baseline.

All participants underwent fecal microbiome sequencing at 6-month follow-up.

All participants underwent fecal microbiome sequencing at 12-month follow-up.

All participants were tested for microbial untargeted metabolites of vaginal secretions at baseline by liquid chromatography tandem mass spectrometric (LC-MS). Measure abundances of vaginal secretions metabolites, metabolic networks, and metabolic pathways activity.

All participants were tested for microbial metabolites of vaginal secretions at 6-month follow-up and 12-month follow-up by LC-MS. Change in vaginal secretions metabolome from baseline to 12-month follow-up were assessed.

All participants were tested for serum metabolites at enrollment by LC-MS. Measure abundances of serum metabolites, metabolic networks, and metabolic pathways activity.

All participants were tested for microbial metabolites of serum at 6-month follow-up and 12-month follow-up by LC-MS. Change in serum metabolome from baseline to 12-month follow-up were assessed.

All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1β (pg/ml) and other cytokines in vaginal secretions at enrollment.

All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1β (pg/ml) and other cytokines in vaginal secretions at 6-month follow-up.

All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1β (pg/ml) and other cytokines in vaginal secretions at 12-month follow-up.

All participants were tested for IL-6 (pg/ml), IL-8 (pg/ml), IL-1β (pg/ml) and other cytokines in vaginal secretions at 24-month follow-up.

Fujian Maternity and Child Health Hospital

Laboratory of Gynecologic Oncology

Neoplasms

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Tim F Greten, M.D.

Background:

There are about 100 trillion microbial cells in a person s gut. This is called the human gut microbiota. When this is disrupted, it can lead to many diseases. Studies show that the gut microbiota in people with cancer is different than that found in healthy people. Researchers want to study links between the gut microbiota and the immune system in people with a liver disease called hepatocellular carcinoma (HCC).

Objective:

To study links between gut microbiota and the immune system in people with HCC.

Eligibility:

People at least 18 years old with HCC. They must be scheduled to have tumors removed by surgery.

Design:

* People having surgery for primary liver tumors at the Mount Sinai Medical Center will be screened for this study.
* At the initial visit, blood, rectal swabs, urine, and stool will be collected. Participants will answer questions about their medical condition.
* Before surgery, blood, rectal swabs, urine, and stool will be collected. This will be done at a routine visit.
* When they have surgery, a piece of liver tissue with the tumor will be collected. This will be sent to the National Cancer Institute for tests.
* After surgery, blood, rectal swabs, urine, and stool will be collected 3 times. This will be done at routine visits.

Background:

The human gut microbiota consists of approximately 100 trillion microbial cells whose disruption leads to many diseases including inflammatory bowel disease and colorectal cancer to name a few. Recent studies have shown that cancer patients have an altered gut microbiota when compared to healthy controls. Intestinal microbiota has been proposed to contribute to the start and progression of a number of liver diseases, such as alcoholic liver disease (ALD), nonalcoholic steatohepatitis (NASH), liver cirrhosis, hepatic encephalopathy (HE), and hepatocellular carcinoma (HCC). We plan to investigate the relationship between the gut microbiota and the immune system in patients with HCC. In recent years, immune regulation at the level of the tumor microenvironment has become very important in different types of cancer.

Objectives:

To collect blood/stool/urine/tumor samples and rectal swabs from HCC patients undergoing resection of primary liver tumors at the Mount Sinai Medical Center and to perform an analysis of the interaction of tumors, immune responses and the gut microbiome.

Eligibility:

* Patients 18 years of age and older
* Patients undergoing liver resection for primary liver cancer
* Patients must be willing to provide informed consent

Design

* Blood, stool, rectal swabs, urine and/or tumor samples may be collected from consenting subjects seen at Mount Sinai Medical Center at the initial visit and/or at follow-up visits.
* Tumor samples will only be obtained from patients undergoing surgery.
* Patients will be asked to answer a questionnaire.

Gut Microbiota in People With Hepatocellular Carcinoma (HCC)

Gut Microbiota in Patients With HCC

Analysis of the interaction of tumors, immune responses and the gut microbiome

National Cancer Institute (NCI)

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Anti-Infective Agents

Antibodies

Immunomodulating Agents

Nivolumab

Atezolizumab

Ipilimumab

Immunoglobulins

Nitrofurazone

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

This cohort will consist of 1000 healthy volunteers from Poland.

This cohort will consist of 160 patients with melanoma.

Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).

Collection of stool samples

Anna Philips, PhD

Emilia Strycharz-Angrecka

Jan Majta

Knowledge about the correlations between the composition of the gut microbiome and a wide range of diseases has substantially increased in recent years. Nonetheless, there is no reference set of information about the microbiome in Poland. The development of such a reference will allow polish scientists conducting research in the field of interaction between gut flora components and such characteristics as lifestyle, certain diseases or patient's responses for treatment. Following the example of such countries as the United States, investigators propose to build a unique set of scientific processed information describing the variability of the polish population microbiome (Polish Microbiome Map). The investigators will provide a reliable dataset that will characterize the gut microbiomes and their diversity in the polish population. Additionally, thanks to the creation of the standard protocol for microbiome data collection the research conducted by the MMP users will be comparable with the information deposited in MMP.

Polish Microbiome Map

Microbial DNA - stool samples sequenced by next-generation sequencing platform.

It includes questions about healthy volunteers' and patients' eating habits that may relate to their health.

The Institute of Bioorganic Chemistry, Polish Academy of Sciences

National Center for Research and Development, Poland

Ardigen

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Dermatologic Agents

Coal Tar

This cohort will consist of 100 patients with non-small cell lung cancer (NSCLC).

This cohort will consist of 30 patients with melanoma (MEL).

Collection of stool, blood (PBMC) and biopsy (FFPE)

Martyna Balawejder

Bozena Augustyn

Michal Warchol, PhD

The goal of the project is to develop and validate the BioForte technology. Its main functionality should be to in silico determine candidates for novel microbiome-based therapeutics and diagnostics. Key challenge to be solved using the technology is to detect the differences in gut microbiome between oncology patients who respond to immunotherapies and the ones who do not respond to this treatment.

This technology employs machine learning methods to replace the laboratory procedure for finding valuable genomic features. Such features can be crucial to identify differences between the two populations (e.g. responders vs non-responders) to target specific strains.

The samples and data collected in this clinical study will be used for clinical validation of BioForte technology. For all patients treated with immunotherapy, stool collection will be performed per patient (one stool collection before setting up immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies). Samples will be sequenced by long-read sequencing technology. In parallel, we will also collect samples of peripheral blood samples (PBMC) and biopsy (FFPE).

stool, biopsy (FFPE) and peripheral blood samples (PBMC)

BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics

Development of BioForte Technology for in Silico Identification of Valuable Genomic Features That Are Candidates for Microbiome-based Therapeutics and Diagnostics.

Microbila DNA - stool samples sequenced by long-read sequencing technology.

Standard follow-up care after cancer treatment.

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Oculocerebral Syndrome With Hypopigmentation

Premenopausal women between 18-40 years of age.

Diagnosed with PCOS using Rotterdam criteria (meet 2 of the 3):

1. chronic oligo- or amenorrhea (irregular periods during more than a year in combination with a cycle length longer than 35 days);
2. total or free T levels above the reference interval and/or excessive facial hair, acne;
3. transvaginal ultrasound with polycystic ovaries.

Exclusion of common medical disorders (normal thyroid function tests and serum prolactin and exclusion of 21-hydroxylase deficiency).

Blood sample will be drawn from participants at study entry.

Blood Draw

Stool will be collected from participants at study entry.

Stool collection

Polycystic Ovary Syndrome is kind of disease with unclear etiology. Recent studies on intestinal microbiota have raised the possibility that dysbiosis of intestinal microbiota maybe a novel theory for the development of Polycystic Ovary Syndrome. Hence, the investigators will compare the intestinal microbiota composition and diversity in PCOS with age, BMI-matched control and then assess whether intestinal microbiota modification is associated with clinical and biological parameters.

The goal of this study is to investigate and compare the composition of the intestinal microbiota in patients with PCOS and age, BMI-matched control. In addition, the investigators will investigate the relationship between alterations in the intestinal microbiota, clinical phenotype, biochemical analysis, body composition, inflammation and food consumption habit. The investigators hypothesize that alterations in the intestinal microbiota are associated with increased immune activation and progression of PCOS. Based on this hypothesis, the investigators propose the following aims:

Aim 1. Identify and enroll cohort with PCOS and age, BMI-matched control to study the role of intestinal microbiota on the development of PCOS.

1. Enroll participants at Drum Tower Hospital. Identify and classify participants through initial clinical evaluation, collect clinical metadata, obtain and process blood and stool samples for analysis.
2. Characterize the intestinal microbiota through quantitative PCR and high throughput sequencing analysis of stool specimens in participants.

Aim 2. Compare sequencing results and metagenomic analysis for study groups with particular attention to bacterial composition and metabolic capacity associated with energy harvest, lipid and carbohydrate transport, enhancement of epithelial barrier integrity and systemic inflammation.

Intestinal Microbiota Survey of Polycystic Ovary Syndrome

The Cross-sectional Study of Intestinal Microbiota in Women With Polycystic Ovary Syndrome and Its Association With Clinical and Biological Parameters

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Chief Physician

Head and Neck Neoplasms

Colonic Neoplasms

Diarrhea

Dysbiosis

Signs and Symptoms, Digestive

Other Dietary Supplements

Herbal and Botanical

Acidophilus

Bifidobacterium

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
Characteristics of Vaginal and Intestinal Microbiota and Cervical HPV Infection	NCT05003505	Intestinal Micr... Vaginal Microbi... HPV Infection	Follow up	20 Years - 65 Years	Fujian Maternity and Child Health Hospital
Gut Microbiota in People With Hepatocellular Carcinoma (HCC)	NCT02599909	Hepatocellular ... Liver Cancer Liver Cell Cari... Liver Neoplasm		18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Polish Microbiome Map	NCT04169867	Melanoma Healthy Volunte... Microbiome Metagenome Immunotherapy	Collection of s...	18 Years -	Ardigen
BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics	NCT04136470	Non Small Cell ... Microbiome Metagenome Immunotherapy Melanoma	Collection of s...	18 Years -	Ardigen
Intestinal Microbiota Survey of Polycystic Ovary Syndrome	NCT02937090	Polycystic Ovar...	Blood Draw Stool collectio...	18 Years - 40 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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
Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation	NCT04935684	Acute Leukemia ... Myelodysplastic... Myeloproliferat... Hodgkin Lymphom... Lymphoma, Non-H... Myeloma Chronic Lymphoc...	Fecal Microbiot...	18 Years -	University Hospital, Clermont-Ferrand
BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics	NCT04136470	Non Small Cell ... Microbiome Metagenome Immunotherapy Melanoma	Collection of s...	18 Years -	Ardigen

Spots Global Cancer Trial Database for intestinal microbiota