FMT-based treatment protocol improves sleep efficiency in chronic insomnia disorder
A randomized, double-blind, placebo-controlled trial found that a fecal microbiota transplantation (FMT)-based treatment protocol incorporating antibiotic pretreatment improved polysomnography-measured sleep efficiency by 13.9 percentage points (95% CI 7.29-20.41, p=0.003) compared to placebo in adults with chronic insomnia disorder. The intervention also reduced wake after sleep onset and showed sustained improvements in subjective insomnia scores from 2 to 6 months.
This article is automatically generated from the structured evidence profile behind the claim above. Scores reflect the quality and quantity of available research, not clinical advice.
FMT-based treatment protocol improves sleep efficiency in chronic insomnia disorder The current body of evidence comprises 1 study, including 1 randomized controlled trial. EvidenceHub rates the overall confidence at 44/100 (low).
The Claim
FMT-based treatment protocol improves sleep efficiency in chronic insomnia disorder
This conclusion is most relevant to: Adults with chronic insomnia disorder (n=80, 40 per group).
What the Research Shows
The conclusion draws on 1 linked study. Highlights from the cited literature:
- ▸Fecal microbiota transplantation-based treatment protocol for chronic insomnia disorder: A randomized, double-blind, placebo-controlled trial. (Journal of internal medicine, 2026) —
How It Works
The proposed biological pathway:
- ▸Antibiotic pretreatment reduces native gut microbiota
- ▸Donor microbiota capsules engraft and increase microbial richness and diversity
- ▸Altered gut microbial community structure influences sleep-regulatory pathways
- ▸Result: Improved objective sleep continuity and sustained subjective insomnia outcomes
Who Might Benefit
Evidence fit by population:
- ▸Adults with chronic insomnia disorder (n=80, 40 per group)
Recommended Dose
N/A (capsule-based FMT, dose not specified in abstract)
Limitations & Caveats
Important context when interpreting this evidence:
- ▸Small sample size (n=80) limits generalizability
- ▸Baseline microbiota composition differences between responders and non-responders suggest treatment heterogeneity not fully explained
- ▸Synbiotic subgroup analyses were exploratory and underpowered
Frequently Asked Questions
What is the primary outcome measured in this study?▼
The primary outcome was polysomnography-measured sleep efficiency at 1 month after treatment.
How large was the improvement in sleep efficiency with the FMT protocol?▼
The FMT-based protocol improved sleep efficiency by 13.9 percentage points compared to placebo (95% CI 7.29-20.41, p=0.003).
Were there any serious adverse events reported?▼
No serious adverse events were reported; treatment was well tolerated with only mild, self-limited adverse events.
Did the study find any factors that predicted treatment response?▼
Yes, baseline microbiota composition differed between responders and non-responders, suggesting that initial gut microbial profile may contribute to treatment heterogeneity.
References
- 1.Gao T, Liu X, Mi W, Shi L, Wang X, Zhu D, Geng F, Fu Y, Yang Y, Li X, Zheng M, Zhu K, Wen K, Yang Y, Zheng Y, Chen S, Sun J, Zhou X, Wang Y, Vitiello MV, Wang Z, Bao Y, Lu L. “Fecal microbiota transplantation-based treatment protocol for chronic insomnia disorder: A randomized, double-blind, placebo-controlled trial..” Journal of internal medicine, 2026. PMID: 42482568 DOI: 10.1111/joim.70137