RecruitingNot Applicable

Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Finland45 participantsStarted 2022-04-30

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: FMT and IBS

Trial details

NCT IDNCT05361785

SponsorHelsinki University Central Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

Contact for this trial

Perttu Arkkila, Professor

+358504272272 perttu.arkkila@hus.fi

View on ClinicalTrials.gov More Irritable Bowel Syndrome trials