Multi-donor FMT to treat adolescents with severe obesity (The Gut Bugs Trial)

The gut microbiome is a contributing factor in the development of metabolic disorders. The overarching goal of this study was to assess the efficacy of using lean multi-donor FMT to treat adolescents with severe obesity. The Gut Bugs Trial recruited 87 adolescents with severe obesity and randomised them 1:1 to receive a single dose of either FMT or placebo capsules. FMT capsules contained concentrated fecal material derived from 4 sex-matched lean donors. Placebo capsules contained saline. Recipients were clinically assessed at baseline, and at 6-, 12-, and 26-weeks post-treatment. The primary objective was a change in BMI SDS at week 6. Secondary objectives included a variety of metabolic health parameters, body composition, and gut microbiome alterations.