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Fecal Microbiota Transplantation to Relieve Symptoms of Irritable Bowel Syndrome Without Constipation
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
Official title: TRApianto di Microbiota Intestinale in Pazienti Affetti da Sindrome Dell'Intestino IRritabile Senza Stipsi: Studio Clinico Randomizzato Controllato in Singolo Centro
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2021-12-23
Completion Date
2025-12-23
Last Updated
2025-03-11
Healthy Volunteers
No
Conditions
Interventions
Fecal microbiota transplantation (FMT)
Single FMT infusion via colonoscopy
Locations (1)
Giovanni Cammarota
Roma, Italy