Actively Recruiting
Fecal Microbiota Transplantation to Relieve Symptoms of Irritable Bowel Syndrome Without Constipation
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-11
35
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Irritable bowel syndrome (IBS) is a complex multifactorial functional disorder, whose pathophysiology is largely associated to an impairment of the intestinal microbiota composition, namely dysbiosis. Thus, the modulation of the gut microbiota has been proposed as a possible therapeutic strategy for IBS patients alongside with current available drugs. Fecal microbiota transplantation (FMT) is a promising strategy to restore intestinal eubiosis. In this randomised double-blind placebo-controlled trial patients diagnosed with IBS without constipation are assigned with 1:1 ratio to receive FMT from healthy donor or autologous FMT (placebo group) to assess the effectiveness of FMT on IBS symptoms and quality of life, to evaluate the safety of FMT among IBS patients and to estimate any change in the gut microbiota composition of IBS patients after the FMT.
CONDITIONS
Official Title
Fecal Microbiota Transplantation to Relieve Symptoms of Irritable Bowel Syndrome Without Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to express and give informed consent
- Age 18 years or older
- Diagnosis of diarrhoea-predominant or unclassified IBS according to Rome IV criteria
- Colonoscopy within the last 5 years ruling out intestinal diseases
You will not qualify if you...
- Use of antibiotics or probiotics within 8 weeks before baseline visit
- Chronic inflammatory bowel diseases like Crohn's disease, ulcerative colitis, indeterminate colitis, or eosinophilic gastroenteritis
- Malignant neoplasms of the gastroenteric tract
- Celiac disease
- Diverticular disease
- Uncontrolled heart failure or severe heart disease with ejection fraction less than 30%
- Severe respiratory failure
- Serious psychiatric conditions or psychological instability as assessed by clinician
- Contraindication to fecal microbiota transplantation due to high risk of colonoscopy complications
- Previous abdominal surgery on the digestive tract (except cholecystectomy, appendectomy, and surgeries not involving digestive tract)
- Presence of cutaneous enterostomy
- Pregnancy or lactation
- Concurrent enrollment in other interventional experimental protocols
- Personality instability or inability to adhere to study procedures
- Any clinical condition judged by investigators to contraindicate study enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Giovanni Cammarota
Roma, Italy
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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