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NCT Number: NCT05361785

Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Fecal Microbiota Transplantation Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Helsinki, Helsinki and Uusimaa, 00290, Finland

Location status: Recruiting

Location contact

Perttu Arkkila, Md.

CONTACT

[email protected]

+358381911 ext. +35838192323

Perttu Arkkila, Professor

CONTACT

[email protected]

+358504272272 ext. +35894711

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FMT

Biological

FMT from healthy donor or placebo

Primary outcomes

The effect of FMT for tolerance of FODMAPs in the IBS patients' diet

Time frame: 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 outcomes

Microbial components explaining the successful broadening of FODMAP diet in IBS patients.

Time frame: 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Perttu Arkkila, Professor

CONTACT

[email protected]

+358504272272 ext. +35894

Perttu Lahtinen, Md

CONTACT

[email protected]

+358381911 ext. +35838192323

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

Paijat-Hame Hospital District
Turku University Hospital
University of Helsinki

Registry information

Acronym: FinFMT-IBS

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2026
First posted: May 5, 2022
Registry last updated: May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting