Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of fecal microbiota transplantation (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.

Official Title
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Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome (IBS)

Intervention / Treatment
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* Other: Fecal transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for patients Signed informed consent Fulfilled Rome III diagnostic criteria for IBS, and frequency of IBS pain or discomfort for at least 2 days a week in the last 12 weeks Age: 18-65 years Exclusion criteria for patients High proportion of butyrate-producing microbiota in fecal samples Known organic gastrointestinal disease (e.g. IBD) Previous complicated gastrointestinal surgery Non-gastrointestinal malignancy Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation Females who are pregnant or breast-feeding Severe endometriosis Antimicrobial treatment 4 weeks prior to first screening visit Antimicrobial prophylaxis (eg. acne, urinary tract infection) Regular consumption of probiotic products 4 weeks prior to randomization Recently (within the last 3 months) diagnosed lactose intolerance Celiac disease Abuse of alcohol or drugs Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial Inclusion criteria for donors Signed informed consent High-butyrate producing microbiota in fecal samples Age: 18-65 years Exclusion criteria for donors Known organic gastrointestinal disease (e.g. IBD, IBS, chronic diarrhea or constipation) Gastrointestinal malignancy or polyposis History of major gastrointestinal surgery (e.g. gastric bypass) Eosinophilic disorders of the gastrointestinal tract Current communicable disease (e.g. upper respiratory tract infection) Known or high risk of infectious diseases such as HIV, hepatitis A, B or C Non-gastrointestinal malignancy Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation Comorbidities such as metabolic syndrome, autoimmune diseases, allergies Chronic pain syndromes (eg. chronic fatigue syndrome, fibromyalgia) Severe or morbid obesity Use of immunosuppressive or chemotherapy agents Antimicrobial treatment or prophylaxis within the last 6 months Females who are pregnant or breast-feeding Known clinically significant abnormal laboratory values Participation in high-risk sexual behaviors Abuse of alcohol or drugs Tattoo or body piercing within the last 6 months Travel to areas with endemic diarrhea during the last 3 months Positive stool testing for C. difficile toxin, ova, parasites, Giarda antigen, cryptosporidium antigen

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fecal transplantation of own stool<br>Autologous fecal transplantation (own stool) | Other: Fecal transplantation<br> <br> |
| Experimental: Fecal transplantation (stool from donor)<br>Allogeneic fecal transplantation (from donor) | Other: Fecal transplantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS version of the gastrointestinal symptom rating scale (GSRS-IBS) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of fecal transplantation on IBS patients' visceral perception (Pain scores on the visual analogue scale during barostat procedure) |  | 2 months | 
| Effect of fecal transplantation on IBS patients' composition of mucosal microbiota (HITChip analysis) |  | 2 months | 
| Effect of fecal transplantation on IBS patients' composition of fecal microbiota (HITChip analysis) |  | 6 months | 
| Effect of fecal transplantation on IBS patients' mucosal immune cell composition (lymphocyte fingerprinting using flow cytometry) |  | 2 months | 
| Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS - severity scoring system (IBS-SSS) |  | 6 months | 
| Effect of fecal microbiota transplantation on the symptoms of IBS patients using the health-related quality of life questionnaire for IBS patients (IBS-QOL) |  | 6 months | 
| Effect of fecal microbiota transplantation on the symptoms of IBS patients using the hospital and anxiety depression scale (HADS) |  | 6 months | 
| Effect of fecal microbiota transplantation on the general health of IBS patients using the SF-36 survey |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal transplantation, microbiota transplantation, irritable bowel syndrome, IBS