Fecal Microbiota Transplantation to Relieve Symptoms of Irritable Bowel Syndrome With Constipation

Condition(s) studied

Investigational drug(s) / intervention(s)

Fecal microbiota transplantation (FMT) Single FMT infusion: 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 with 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

Primary outcome measure(s)

• Improving IBS symptoms assessed with the IBS severity scoring system (IBS-SSS) — 365 days
  To assess the effectiveness of healthy donor FMT in improving the symptoms of IBS without constipation compared to autologous microbiota transplantation using the IBS-SSS (\< 175: mild IBS; 175-300: moderate IBS; \> 300: severe IBS)
• Number and severity grade of adverse events after FMT — 365 days
  To assess the number and severity grade of adverse events occurred after FMT

Trial sites (1)

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy

Other trials for the same condition