Effect of faecal microbial transplant via colonoscopy in patients with severe obesity and insulin resistance: A randomized double‐blind, placebo‐controlled Phase 2 trial
Authors' conclusion
Overall, in those with obeisty, allogenic FMT via colonoscopy induced favourable changes in IM, metabolites, pathway representations and networks even though other metabolic variables did not change. LDL and appetite variables may also benefit.
Study context
- Population
- Subjects with BMI ≥ 35 kg/m² and insulin resistance
- Participants
- 15 vs 13
- Comparison
- Allogenic faecal microbial transplant (FMT) vs autologous FMT via colonoscopy
- Allogenic FMTn = 15
- Autologous FMTn = 13reference
- Primary endpoint
- HOMA-IR
- Follow-up
- 3 months
Methodological detailsdouble-blind, placebo-controlled, phase 2, 1:1 randomisation in blocks of four
- Double-blind
- Placebo-controlled
- Phase 2
- 1:1 randomisation in blocks of four
Primary result
As reported in the abstract
- Homeostatic model assessment of insulin resistance (HOMA-IR) and clinical variables did not change significantly in allogenic vs autologous
Secondary outcomes
| Outcome | P value |
|---|---|
| Intestinal microbiome · 1 and 3 monthsIM and metabolites changed favourably with allogenic FMT | P < 0.05 |
Intestinal microbiome · 1 and 3 months
- At 1 month, Coprococcus, Bifidobacterium, Bacteroides and Roseburia increased and Streptococcus decreased; at 3 months, Bacteroides and Blautia increased; several species also changed significantly
Serum/faecal metabolites · 1 and 3 months
- At 1 month, serum kynurenine decreased and faecal indole acetic acid and butenylcarnitine increased; at 3 months, serum isoleucine, leucine, decenoylcarnitine and faecal phenylacetic acid decreased
Metagenomic pathways and network analyses
- Significantly enhanced in allogenic vs autologous
LDL and appetite measures
- Improved in allogenic (P < 0.05) but not in autologous
Original publication
Effect of faecal microbial transplant via colonoscopy in patients with severe obesity and insulin resistance: A randomized double‐blind, placebo‐controlled Phase 2 trial. Diabetes Obes Metab. Published 28 October 2022. doi:10.
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