Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Study Overview
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Brief Summary
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Previous studies have shown that stool transplantation (FMT) have positive effect in symptoms for some patients with irritable bowel syndrome (IBS). Studies have shown that it is possible by FMT to reverse the microbiome of the recipient's intestine in the direction of the microbiome of the donor. The effect on eating habits for engraftment of microbiome by FMT is unknown. The purpose of this study is to investigate whether FMT relieves FODMAP diet extension without worsening intestinal symptoms in IBS patients.

Detailed Description
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This is a plasebo controlled study in which we study the effect and safety of FMT in patients who have IBS and have used FODMAP diet. FMT is assessed by colonoscopy route and therafter the patietns receive twice FMT enema from healthy donor or plasebo..

Official Title
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Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Conditions
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Irritable Bowel Syndrome, Fecal Microbiota Transplantation

Intervention / Treatment
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* Biological: FMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, age 18-75 years, knowledge of the Finnish language IBS patients have been diagnosed with the Rome IV- criteria, all IBS-subtypes will be accepted to the trial The patient must consume low FODMAP diet to control IBS symptoms Patient must sign the informed consent Exclusion Criteria: Diagnosed allergies to food components in the study dietary protocol Pregnancy and breastfeeding Antibiotic treatment less than three months prior enrolment Faecal incontinence, i.e., inability to retain enema Abuse of drugs, alcohol or medications Other diagnosis besides IBS causing GI symptoms, these include IBD, microscopic colitis, coeliac disease and bile acid diarrhoea. Severe psychiatric or neurologic condition decreasing patient's compliance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single Group Assignment
Interventional Model Description: RCT, randomaization 2/3 FMT, 1/3 placebo
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FMT form healthy donor<br>FMT from healthy donor | Biological: FMT<br>* FMT from healthy donor or placebo<br>|
| Placebo Comparator: FMT plasebo<br>FMT plasebo | Biological: FMT<br>* FMT from healthy donor or placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of FMT for tolerance of FODMAPs in the IBS patients' diet | With this study we aim to investigate if FMT treatment promotes inclusion and tolerance of FODMAPs in the IBS patients' diet. | FMT and IBS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial components explaining the successful broadening of FODMAP diet in IBS patients. | We aim to investigate what are the microbial components explaining the successful broadening of their diet and identify microbial taxa engrafted from the donor explaining the dietary modifications. | Microbiome and FODMAP | 
| GI symptoms and bacterial fermentaiton status in IBS | Aim to investigate the gastrointestinal symptom change and see how changes in bacterial fermentation status (detected with hydrogen breath test) modulates the patients' symptoms and if this is related to the FMT treatment. | Bacterial fermentation status and IBS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FMT, IBS, FODMAP