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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.

Last updated: Jul 27, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score44/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. Fecal microbiota transplantation-based treatment protocol for chronic insomnia disorder: A randomized, double-blind, placebo-controlled trial.

observational

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 · Journal of internal medicine (2026)

Participants: N/A
Duration: 6 months (follow-up at 1, 2, and 6 months)
Intervention: Short-course antibiotic pretreatment followed by donor microbiota capsules (FMT-based protocol), with or without synbiotic supplementation
Outcome: Polysomnography-measured sleep efficiency (primary), wake after sleep onset, Insomnia Severity Index, Pittsburgh Sleep Quality Index, safety, microbiota composition
Effect Size: Adjusted between-group difference of 13.9 percentage points in sleep efficiency
Population: Adults with chronic insomnia disorder (n=80, 40 per group)

Result:

PubMed: 42482568DOI: 10.1111/joim.70137

Mechanism Graph

Antibiotic pretreatment reduces native gut microbiota
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Donor microbiota capsules engraft and increase microbial richness and diversity
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Altered gut microbial community structure influences sleep-regulatory pathways
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Result: Improved objective sleep continuity and sustained subjective insomnia outcomes

Limitations

  • ⚠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.

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References

  1. 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
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.