Faecal microbiota transplantation in irritable bowel syndrome (REFIT2): a randomised, double-blind, placebo-controlled, phase 3 trial.

Faecal microbiota transplantation did not significantly improve symptoms in IBS patients, with only 40% showing a ≥75-point reduction in IBS-SSS at 90 days.

• Why it matters: Understanding effective treatments for IBS is crucial, as current options are limited and often ineffective. Restoring healthy gut microbiota has been proposed as a potential therapy, but its efficacy remains uncertain.
• What they did: A phase 3, double-blind, placebo-controlled trial enrolled 450 adults with moderate-to-severe IBS across five Norwegian hospitals, comparing donor FMT to placebo via a single rectal enema, measuring symptom change at 90 days.
• The result: The study found no significant difference between groups, with an absolute difference of 1.9 percentage points (p=0.76), indicating microbiota modulation alone may not be sufficient to alleviate IBS symptoms.