Actively Recruiting
Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance
Led by Helsinki University Central Hospital · Updated on 2022-05-13
45
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
H
Helsinki University Central Hospital
Lead Sponsor
T
Turku University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of fecal microbiota transplantation (FMT) on patients with irritable bowel syndrome (IBS) who follow a low FODMAP diet to control their symptoms. Previous studies suggest FMT can positively affect IBS symptoms by altering the recipient's gut microbiome to resemble that of a healthy donor. This study aims to see if FMT can allow IBS patients to tolerate a broader range of FODMAP foods without worsening their intestinal symptoms. This is a placebo-controlled trial where participants receive an initial FMT delivered via colonoscopy, followed by two FMT enemas from either a healthy donor or a placebo. The study compares the effects and safety of these treatments to understand how FMT influences diet tolerance and gut microbiome changes in IBS patients. Participants will be monitored for changes in their tolerance to FODMAP foods and gastrointestinal symptoms. Researchers will analyze the gut microbial composition and bacterial fermentation status to identify factors associated with successful diet broadening. The study includes assessments of symptom changes and microbiome samples, with participation lasting throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years who understand Finnish
- Diagnosed with irritable bowel syndrome (IBS) using Rome IV criteria, all IBS subtypes accepted
- Currently following a low FODMAP diet to control IBS symptoms
- Signed informed consent form
You will not qualify if you...
- Diagnosed allergies to foods in the study diet
- Pregnant or breastfeeding
- Received antibiotic treatment within 3 months before enrollment
- Faecal incontinence or inability to retain enema
- Abuse of drugs, alcohol, or medications
- Other gastrointestinal diagnoses causing symptoms, including inflammatory bowel disease, microscopic colitis, coeliac disease, or bile acid diarrhoea
- Severe psychiatric or neurological conditions affecting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of treatment period as per protocol (not specified)
Participants receive fecal microbiota transplantation (FMT) by colonoscopy followed by two FMT enemas from a healthy donor or placebo.
1 colonoscopy visit and 2 enema visits
Trial Site Locations
Total: 1 location
1
Helsinki University Hospital
Helsinki, Helsinki and Uusimaa, Finland, 00290
Actively Recruiting
Research Team
P
Perttu Arkkila, Professor
P
Perttu Lahtinen, Md
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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