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The question of whether altering gut microbiota can affect overall metabolism is generating significant interest (1).
NCT02530385 - FMT-TRIM - Fecal Microbiota Transplantation (FMT) vs Placebo & Adiposity / Obesity is a randomized clinical phase I/II treatment trial studying Fecal Microbiota Transplantation (FMT) or placebo in 24 randomized patients with Adiposity / Obesity (BMI ≥30 kg/m^2^) (1).
Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp
In the study, there were no statistically significant improvements in insulin sensitivity in the FMT group compared to the placebo group. The FMT group showed a change of +5% ± 12%, while the placebo group exhibited a change of −3% ± 32%. The mean difference was 9%, with a 95% confidence interval (CI) ranging from −5% to 28% (p = 0.16) (1).
For most secondary metabolic outcomes, no statistically significant differences were observed between the groups:
Variable engraftment of donor bacterial groups was observed among FMT recipients, and this persisted throughout the 12-week study period (1).
There were no significant differences in adverse events (AEs) between the groups, with 10 events in the FMT group versus 5 in the placebo group (p = 0.09). Importantly, no serious adverse events related to FMT were reported (1).
In a study involving adults with obesity, the weekly administration of FMT capsules led to the engraftment of gut microbiota in most participants for a duration of at least 12 weeks. However, despite this engraftment, the study did not reveal any clinically significant metabolic effects (1).
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