Repeated fecal microbiota transplantations (FMTs) are safe and lead to increased and sustained engraftment of donors’ microbiota in patients with obesity and diabetes, according to a study published in Gut.

A single FMT alone can lead to modest engraftment of donors’ microbiota in subjects with obesity and metabolic syndrome. However, its overall impact is unknown. Lifestyle modifications have also been shown to affect microbiota composition in both animal and humans. Therefore, researchers studied whether combining FMT with lifestyle modifications could enhance the engraftment of favorable microbiota in patients with obesity and type 2 diabetes mellitus (T2DM) by conducting a double-blind, randomized, placebo-controlled trial (ClinicalTrials.gov identifier: NCT03127696).

Sixty-one subjects with obesity and T2DM were randomly assigned to three parallel groups: FMT plus lifestyle intervention (LSI), FMT alone, or sham transplantation plus LSI every 4 weeks for up to week 12. The FMT solution was prepared from 6 healthy lean donors and fecal metagenomic sequencing was performed at baseline, weeks 4, 16, and 24.

The primary outcome was the proportion of subjects acquiring ≥20% of microbiota from lean donors at week 24, which occurred in 100%, 88.2%, and 22% of patients in the FMT plus LSI, FMT alone, and sham plus LSI groups, respectively (P <.0001). Repeated FMTs significantly increased the engraftment of lean-associated microbiota (P <.05).

FMT with or without LSI increased butyrate-producing bacteria and combining LSI and FMT led to an increase in Bifidobacterium and Lactobacillus compared with FMT alone (P <.05). The FMT plus LSI group had reduced total and low-density lipoprotein cholesterol and liver stiffness at week 24 compared with baseline (P <.05).

The authors concluded, “Our study has, for the first time, demonstrated that FMT repeated at scheduled intervals led to increased and sustainable engraftment of microbiota from lean donors in obese recipients with T2DM that persisted for at least 6 months.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

Reference

Ng SC, Xu Z, Mak JWY, et al. Microbiota engraftment after faecal microbiota transplantation in obese subjects with type 2 diabetes: a 24-week, double-blind, randomised controlled trial. Gut.  Published online March 30, 2021. doi: 10.1136/gutjnl-2020-323617