Symptoms and General Pathology

All Conditions

Dysbiosis

Patients undergo once WMT a day for three consecutive days.

Washed microbiota suspension (5u) delivered through nasogastric tube, nasojejunal tube or oral. Dose and frequency: 5u, three times.

Washed Microbiota Transplantation (WMT)

Faming Zhang, MD,PHD

Faming Zhang, MD, PhD

Gut microbiota, known as "unrecognized organs", is closely related to the occurrence and development of tumors. Cancer is thought to occur secondary to local chronic inflammation. And some bacteria, such as Helicobacter pylori, also have direct genotoxicity, changing intracellular signaling pathways and thus causing abnormal cell growth. Systemic intestinal dysbiosis may lead to cancer, and fecal microbiota transplantation (FMT) can be a new weapon in anti-cancer treatment.Washed microbiota transplantation (WMT), a new stage of FMT, is based on the automatic microfiltration machine (GenFMTer, Nanjing, China) and the following repeated centrifugation plus suspension with support from specific facilities. The investigators conducted a prospective, one-arm, open-label study on the efficacy and safety of WMT in the treatment of oncotherapy-related complications. This study aimed to exploring the therapeutic potential of WMT in the treatment of oncotherapy-related intestinal complications and improving the quality of life of patients.

Gut microbiota, known as "unrecognized organs", is closely related to the occurrence and development of tumors. Cancer is thought to occur secondary to local chronic inflammation. And some bacteria, such as Helicobacter pylori, also have direct genotoxicity, changing intracellular signaling pathways and thus causing abnormal cell growth. Systemic intestinal dysbiosis may lead to cancer, and fecal microbiota transplantation (FMT) can be a new weapon in anti-cancer treatment. The reduction of intestinal flora diversity may lead to intestinal dysbiosis, thereby reducing the body immunity and promoting the formation and development of neoplasm. It has been reported that FMT can be used to treat melanoma, liver cancer and prostate cancer after immunotherapy failed. But the mechanism of gut microbiota on the tumor itself remains to be further explored. In 2019, an Italian study reports the efficacy of FMT for diarrhea induced by tyrosine kinase inhibitors in the treatment of renal cell carcinoma, suggesting the therapeutic potential of gut microbiota for tumor-related gastrointestinal complications \[1\].

Fecal Microbiota transplantation (FMT), the most classic way to treat diseases using gut microbiota \[2\], refers to the transplantation of functional microbiota in the feces of healthy people into the intestines of patients. It can reconstruct the overall gut microbiota of patients, thus treating gastrointestinal diseases and external gastrointestinal diseases of patients. In 2013, FMT was for the first time coined into the treatment guidelines on recurrent CDI, and now it plays an important role as a key treatment for clostridium difficile infection \[3\]. Washed microbiota transplantation (WMT), a new stage of FMT, is based on the automatic microfiltration machine (GenFMTer, Nanjing, China) and the following repeated centrifugation plus suspension with support from specific facilities. Compared with manual FMT, WMT can reduce the rate of adverse events (such as fever, diarrhea, abdominal pain, abdominal distension, nausea and vomiting, etc.) without affecting the efficacy. In addition, Zhang et al. have proved that WMT is better than the manual preparation of FMT in improving safety, enriching the precise amount of microbiota and quality controllable in practice \[4\]. In December 2019, A panel of 28 experts from 22 hospitals or institutes in 15 cities has contributed to the "Nanjing consensus on methodology of washed microbiota transplantation" according to the international standards, and the consensus is published in Chinese Medical Journal in July 2020 \[5\].

Therefore, the investigators conducted a prospective, one-arm, open-label study on the efficacy and safety of WMT in the treatment of oncotherapy-related intestinal complications. This study aimed to exploring the therapeutic potential of WMT in the treatment of oncotherapy-related intestinal complications and improving the quality of life of patients.

Washed Microbiota Transplantation for The Treatment of Oncotherapy-Related Intestinal Complications

Efficacy and Safety of Washed Microbiota Transplantation for The Treatment of Oncotherapy-Related Intestinal Complications

Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0

Stool frequency and consistency will be evaluated according to The Bristol Stool Form Scale (BSFS).

New onset of symptoms and the exacerbation of previous symptoms were recorded as adverse events (AEs)

Changes in functional status of patients will be assessed according to the Karnofsky Performance Status (KPS) scale (ranging from 0 \[dead\] to 100 \[normal activity, no evidence of disease\])

The Second Hospital of Nanjing Medical University

Professor, Gastroenterology

Neoplasms

Digestive System Diseases

Head and Neck Neoplasms

Colonic Neoplasms

Diarrhea

Signs and Symptoms, Digestive

Other Dietary Supplements

All Drugs and Chemicals

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

Simone de Vasconcelos Generoso

Luísa Martins Trindade

Rodrigo Gomes Silva

Maria Isabel Toulson Davisson Correia

Federal University of Minas Gerais

Sponsor-Investigator

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Syndrome

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia

Leukemia, Lymphoid

Lymphoma, Non-Hodgkin

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Graft vs Host Disease

Hodgkin Disease

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Bone Marrow Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Homologous Wasting Disease

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Pharmaceutical Solutions

Anti-Infective Agents

Glycerol

Patients randomized in the "FMT group" will received FMT. FMT product will be made by the the pharmacy of the Clermont-Ferrand University Hospital from stools of healthy volunteer donors within 6 hours after defecation in order to preserve the viability of the bacteria. The preparation will be standardized: 50g aliquots will be prepared and diluted in 250mL of 0.9% NaCl containing 10% glycerol, until a homogeneous suspension is obtained. The preparation will be rapidly frozen at -80°C until use, with a maximum shelf life of 18 months.

The comparator group will be constituted by patients randomized in the "no FMT" group. For ethical reasons, these patients will not receive any FMT and therefore no enema or colic preparation. No placebo will be administered. Prophylactic anti-infective treatments can be introduced at any time.

Patients randomized in the "FMT group" will received FMT within 4 weeks following neutrophils recovery after the allo-HSCT procedure. The stool transplant will be done by enema. The day before FMT, patient will undergo bowel cleansing by ingestion of two liters of polyethylene glycol solution. The day of FMT, a colon cleanse enema will be performed in the morning and FMT will be delivered around two hours after the cleanse enema. This colic preparation is essential to optimize the results of FMT.

The enema (50g of stools diluted in 250mL of NaCl 0.9%) will be performed by a qualified member of the study team (nurse) by using a rectal cannula (within 6 hours of thawing). The enema will have to be kept by the patient for as long as possible and at least 30 minutes.

Fecal Microbiota Transplantation

Lise LACLAUTRE

Magalie Magalie, MD

Sylvie François, MD

Etienne Daguindau, MD

Christian Dualé, MD, PhD

Jacques-Olivier Bay, MD, PhD

Aurélie Ravinet, MD

Claude-Eric Bulabois, MD

David Beauvais, MD

Pascal Turlure, MD

Marie-Virginie Larcher, MD

Marie-Therese Rubio, MD

Patrice Chevallier, MD

Michel Loschi, MD

Ambroise Marçais, MD

Stéphanie Nguyen, MD, PhD

Marie Robin, MD

Carmen Botella Garcia, MD

Deborah Desmier, MD

Anne-Lise Menard, MD

Emmanuelle Tavernier, MD

Anne Huynh, MD

Jacques-Olivier BAY, MD, PhD

Stéphanie NGUYEN, MD, PhD

The aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-HSCT) complications and particularly Graft versus Host Disease (GvHD).

The hypothesis of this study is that allogeneic FMT may improve outcomes of these patients.

The TMF-Allo study is a prospective, open-label, multi-center, parallel, randomized phase II clinical trial comparing a group patients with FMT and a control group of patients without FMT.

The main objective of this study is to assess the effect of allogeneic FMT versus no treatment on Graft-versus-host disease and Relapse-Free Survival (GRFS) at one year in adult patients treating with myelo-ablative allo-HSCT for haematologic malignancy.

The secondary objectives are to evaluate :

* Overall survival, progression-free survival at 1 and 2 years,
* The haematological evolution,
* The evolution of infections,
* The tolerance and safety of the TMF carried out in post-transplant,
* The evolution of the composition and diversity of the microbiota in allograft patients receiving TMF or not.

A group patients will receive Fecal Microbiota Transplantation (FMT) within 4 weeks following neutrophils recovery after the allogeneic hematopoietic stem cell transplantation procedure and a control group of patients will not receive FMT.

Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies

Full protocol, participant-level data, statistical codes, trial datasets and analyses will be made available on request from the corresponding author after examining the request.

GRFS is a composite endpoint of GvHD-free/relapse-free survival in which events include grade II-IV acute GvHD, moderate and severe chronic GvHD, relapse, or death in the first year post-HSCT. GRFS will be measured at one year after allo-HSCT and compared between both groups of patients.

Overall survival is defined as the time period between the date of randomization and the date of death, regardless of its cause.

Progression-free survival is defined as the time period between the date of randomization and the date of disease relapse or progression or death, regardless of its cause.

Haematopoietic reconstitution is assessed by: 1/ turnaround time of polynuclear neutrophils \>0.5.10\^9/L (first day within a period of three consecutive days); 2/ spontaneous platelet turnaround time \>20.10\^9/L (two days with no platelet transfusion within the previous three days); 3/ spontaneous platelet turnaround time \>50.10\^9/L (two days with no platelet transfusion within the previous three days); 4/ the number of transfusions of red blood cells and platelets between D0 and D100

Engraftment rates are evaluated by a chimerism measure (by molecular biology)

Acute GvHD severity is defined according to MAGIC criteria. It will be notified by specifying the location (liver, skin, gut ...), the severity score (II to IV), the treatment applied and the efficacy of treatment. GvHD occurrence will be notified every week until D30 (minimum) or until hospital discharge, then monthly until D180 and at D270, D360, D540 and D720.

Chronic GvHD severity will be defined according to NIHCC criteria. It will be notified by specifying the location (liver, skin, gut ...), the severity score (II to IV), the treatment applied and the efficacy of treatment. GvHD occurrence will be notified every week until ungraftment, then monthly until D180 and at D270, D360, D540 and D720.

Transplant-related mortality is defined as death due to causes unrelated to the underlying disease.

Infectious complications will be notified every week up to day 30 (minimum) or until hospital discharge, then every month up to D180 and from D270 to D360, according to the existence of a documented bacteraemia, germ resistance, type and number of days of curative antibiotherapy used; the existence of a documented fungal infection and the type and number of days of curative antifungal treatment; the existence of a documented viral infection and the type and number of days of curative antiviral treatment; the need of an intensive care unit transfer due to an infectious complication.

Severe infections will be defined according to GREFIG score : bactearemia with severe sepsis, complex bactearemia (with deep organ involvement), candidemia (at least one positive blood culture) with sepsis or deep infected site, proven or probable aspergillosis pneumonia, severe varicella-zoster virus infection (involvement of a deep organ or associated coagulopathy), any viral encephalitis, CMV infection with lung or digestive location, Pneumocystis jiroveci pneumonia, toxoplasmosis with involvement of organ or central nervous system, any acute pneumonia with PaO2 less than or equal to 65mmHg, any sepsis requiring transfer to an intensive care unit.

Impact of FMT on multi-resistant bacteria, extended-spectrum beta-lactamases and Clostridium difficile infection will be assessed by evaluation of persistence or disappearance of these pathogenic bacteria after FMT.

Each unexpected event that could be in relation with FMT will be notified: abdominal pain, diarrhea, bacterial translocation or any adverse effect attributed to the enema.

The quality of life will be auto-evaluated by the patients using a validated questionnaire: European Organisation for Research and Treatment of Cancer- Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

The intestinal microbiota composition and diversity will be assessed by 16S-rRNA sequencing performed prospectively in all patients with FMT and without FMT.

The intestinal microbiota composition and diversity will be assessed by 16S-rRNA sequencing performed prospectively in all stool donnors.

A blood collection will be set up from blood samples collected on patients from both groups. These samples will be used for a metabolomic study (tryptophan, indoleamine 2,3-dioxygenase, short chain fatty acid, bile acids).

A blood collection will be set up from blood samples collected on patients from both groups. These samples will be used for an analysis of anti-microbiota IgG and IgA.

A blood collection will be set up from blood samples collected on stool donnors. These samples will be used for a metabolomic study (tryptophan, indoleamine 2,3-dioxygenase, short chain fatty acid, bile acids).

A blood collection will be set up from blood samples collected on stool donnors. These samples will be used for an analysis of anti-microbiota IgG and IgA.

A stool collection will be carried out from stool samples collected on patients from both groups.These samples will be used for an analysis of the virome evolution.

A stool collection will be carried out from stool samples collected on stool donnors.These samples will be used for an analysis of the virome evolution.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Washed Microbiota Transplantation for The Treatment of Oncotherapy-Related Intestinal Complications	NCT04721041	Intestinal Comp... Cancer	Washed Microbio...	18 Years -	The Second Hospital of Nanjing Medical University
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
Washed Microbiota Transplantation for The Treatment of Oncotherapy-Related Intestinal Complications	NCT04721041	Intestinal Comp... Cancer	Washed Microbio...	18 Years -	The Second Hospital of Nanjing Medical University

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