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

RecruitingNAAges 18 Years - anyAllFondazione Policlinico Universitario Agostino Gem…
NCT05803980 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Fecal microbiota transplantation (FMT)
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Where

1 site
Giovanni Cammarota
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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