NCT05361785 Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance
| NCT ID | NCT05361785 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helsinki University Central Hospital |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2022-04-30 |
| Primary Completion | 2024-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2022-04-30 with a primary completion date of 2024-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Perttu Arkkila, Professor
PRINCIPAL INVESTIGATOR
Head physician
Frequently Asked Questions
Who can join the NCT05361785 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05361785 currently recruiting?
Yes, NCT05361785 is actively recruiting participants. Contact the research team at perttu.arkkila@hus.fi for enrollment information.
Where is the NCT05361785 trial being conducted?
This trial is being conducted at Helsinki, Finland.
Who is sponsoring the NCT05361785 clinical trial?
NCT05361785 is sponsored by Helsinki University Central Hospital. The principal investigator is Perttu Arkkila, Professor at Head physician. The trial plans to enroll 45 participants.