Fecal microbiota transplantation for IBS patients with food intolerance
Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance
NA · Helsinki University Central Hospital · NCT05361785
This study is testing whether fecal microbiota transplantation can help people with irritable bowel syndrome and food intolerance feel better and eat a wider variety of foods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Helsinki University Central Hospital (other) |
| Locations | 1 site (Helsinki, Helsinki and Uusimaa) |
| Trial ID | NCT05361785 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of fecal microbiota transplantation (FMT) on patients with irritable bowel syndrome (IBS) who are following a low FODMAP diet. It is a placebo-controlled trial where participants will receive either FMT or a placebo via enema, with the aim of assessing the safety and efficacy of FMT in alleviating symptoms and allowing for dietary expansion. The study will monitor changes in intestinal microbiome and symptom relief in IBS patients. The research is conducted at multiple locations, including Helsinki University Hospital.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 diagnosed with IBS who are currently on a low FODMAP diet.
Not a fit: Patients with other gastrointestinal disorders or severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for IBS patients struggling with food intolerances.
How similar studies have performed: Previous studies have shown positive effects of FMT in IBS patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Helsinki, Helsinki and Uusimaa
- Helsinki University Hospital — Helsinki, Helsinki and Uusimaa, Finland (RECRUITING)
Study contacts
- Principal investigator: Perttu Arkkila, Professor — Head physician
- Study coordinator: Perttu Arkkila, Professor
- Email: perttu.arkkila@hus.fi
- Phone: +358504272272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Irritable Bowel Syndrome, Fecal Microbiota Transplantation, FMT, IBS, FODMAP