Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Helsinki University Central Hospital45 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Irritable Bowel Syndrome Fecal Microbiota Transplantation

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: FMT and IBS

Secondary Outcomes

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.

Time frame: 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.

Time frame: Bacterial fermentation status and IBS

Central Contacts

Perttu Arkkila, Professor

CONTACT

+358504272272 perttu.arkkila@hus.fi

Perttu Lahtinen, Md