Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Not Applicable

Recruiting

• Conditions: Fecal Microbiota Transplantation; Irritable Bowel Syndrome
• Interventions: Biological: FMT

• Registration Number: NCT05361785
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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

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..

Study Timeline

• Study Start: 2022-04-30
• Study First Submitted: 2022-04-30
• Study First Submitted QC: 2022-04-30
• Status Verified: 2022-05
• Study First Posted: 2022-05-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-13
• Primary Completion: 2024-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FMT plasebo	FMT	FMT plasebo
FMT form healthy donor	FMT	FMT from healthy donor

Primary Outcome Measures

Name	Time	Method
The effect of FMT for tolerance of FODMAPs in the IBS patients' diet	FMT and IBS	With this study we aim to investigate if FMT treatment promotes inclusion and tolerance of FODMAPs in the IBS patients' diet.

Secondary Outcome Measures

Name	Time	Method
Microbial components explaining the successful broadening of FODMAP diet in IBS patients.	Microbiome and FODMAP	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.
GI symptoms and bacterial fermentaiton status in IBS	Bacterial fermentation status and 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.

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Helsinki And Uusimaa, Finland