A randomized, double-blind, placebo-controlled phase Ib treatment trial to evaluate Fecal Microbiota Transplantation (FMT) or placebo in 25 randomized patients (aged 4 to 17 years) with active Ulcerative Colitis (UC) (1)
Pediatric UC activity index, C-reactive protein, or fecal calprotectin (1)
92% of the children who received Fecal Microbiota Transplantation (FMT) showed improvement in their condition, compared to 50% of those who received a placebo after 6 weeks. This means that the treatment was 1.8 times more effective, with a confidence interval of 1.1 to 3.7. After 12 months, 75% of the children who received FMT continued to show improvement. The diversity of bacteria was generally higher in those who received FMT compared to the placebo group. Some specific types of bacteria, like Alistipes and Escherichia, were linked to better outcomes (1).
Our trial, despite facing numerous challenges, provides the first pilot randomized controlled trial (RCT) evidence suggesting that fecal microbiota transplantation (FMT) could play a significant role in alleviating symptoms and reducing inflammatory markers in pediatric ulcerative colitis (UC) (2)
(1)