Status:
RECRUITING
Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
Turku University Hospital
University of Helsinki
Conditions:
Irritable Bowel Syndrome
Fecal Microbiota Transplantation
Eligibility:
All Genders
18-75 years
Phase:
NA
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 re...
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05361785
Start Date
April 30 2022
End Date
July 31 2026
Last Update
May 13 2022
Active Locations (1)
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1
Helsinki University Hospital
Helsinki, Helsinki and Uusimaa, Finland, 00290