Finding the best method for fecal microbiota transplantation in IBS patients
The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
This study is testing which method of fecal microbiota transplantation works better for adults with irritable bowel syndrome to help improve their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Turku University Hospital Government |
| Locations | 3 sites (Lahti, Paijat-Hame and 2 other locations) |
| Trial ID | NCT05874830 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the optimal route for fecal microbiota transplantation (FMT) in patients suffering from irritable bowel syndrome (IBS). Researchers will compare outcomes based on fecal microbiome samples and symptom questionnaires to assess differences in symptom severity between FMT administered via duodenogastroscopy and colonoscopy. IBS is a prevalent condition that significantly impacts quality of life, and this study seeks to explore the efficacy of FMT as a treatment option. The study will include adult participants aged 18-70 with moderate to severe IBS symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 who have a diagnosis of IBS and experience moderate to severe symptoms.
Not a fit: Patients with other gastrointestinal diagnoses or those currently on antibiotics or probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with irritable bowel syndrome.
How similar studies have performed: Previous studies on fecal microbiota transplantation for IBS have shown mixed results, but some methods, like FMT via gastroscopy, have demonstrated promising outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult * 18-70 years * known of Finnish language * IBS, (new or old diagnosis according to Roma III or IV criteria), all subtypes * Informed consent * Moderate to severe IBS symptoms, IBS-SSS \> 175 Exclusion Criteria: * Pregnancy * Antibiotic or probiotic treatment, on-going or previous month * Abuse of drugs, alcohol or medications * Other diagnosis besides IBS causing the GI symptoms, such as IBD, microscopic colitis or bile acid diarrhea
Where this trial is running
Lahti, Paijat-Hame and 2 other locations
- Central hospital of Päijät-Häme — Lahti, Paijat-Hame, Finland (Recruiting)
- Helsinki University Hospital — Helsinki, Uusimaa, Finland (Recruiting)
- Turku university hospital — Turku, Varsinais-Suomi, Finland (Recruiting)
Study contacts
- Study coordinator: Teemu T Puodinketo, MD
- Email: teemu.puodinketo@tyks.fi
- Phone: +35823139427
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.