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Clinical Trials in Italy / NCT05803980
Recruiting Not applicable

Fecal Microbiota Transplantation to Relieve Symptoms of Irritable Bowel Syndrome Without Constipation

NCT05803980 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Not applicable
Started
2021-12-23
Last updated
2025-03-11

Condition(s) studied

Irritable Bowel Syndrome

Investigational drug(s) / intervention(s)

Fecal microbiota transplantation (FMT)

Fecal microbiota transplantation (FMT): Single FMT infusion via colonoscopy

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Ability to express and give informed consent * Age ≥ 18 years * Diagnosis of diarrhoea-predominant or unclassified IBS, according to the Rome IV criteria * Have performed a colonoscopy within the last 5 years that has ruled out intestinal diseases Exclusion Criteria: * Taking antibiotics or probiotics within the 8 weeks before the baseline visit * Patients with chronic inflammatory bowel disease (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 EF \< 30% * Severe respiratory failure * Serious psychiatric conditions or psychological instability according to the clinician * Contraindication to fecal microbiota transplantation (high risk of complications related to colonoscopy) * Previous abdominal surgery on the gastroenteric tract (except cholecystectomy, appendectomy and other types of surgery not involving the digestive tract) * Patients with cutaneous enterostomy * Pregnancy or lactation * Concurrent enrollment in other interventional experimental protocols * Personality unstable or unable to adhere to protocol procedures * Any clinical condition which, in the opinion of the investigators, may contraindicate enrollment in the study

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Giovanni Cammarota Roma Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05803980 on ClinicalTrials.gov ↗ ← All trials in Italy