Longitudinal Efficacy of Donor Microbiota Capsules in Adults with Chronic Insomnia

Article Impact Level: HIGH
Data Quality: STRONG
Summary of  Journal of Internal Medicine https://doi.org/10.1111/joim.70137 
Dr. Teng Gao  et al.

Points

A multicenter randomized double-blind placebo-controlled trial evaluated whether an oral fecal microbiota transplantation protocol incorporating antibiotic pretreatment could effectively alleviate symptoms in adults diagnosed with chronic insomnia disorder.
Overnight polysomnography conducted one month after intervention demonstrated that participants receiving donor fecal microbiota capsules experienced significantly higher sleep efficiency alongside reduced wake after sleep onset.
Patient questionnaires administered from two to six months post-treatment revealed sustained improvements in subjective sleep quality scores among the intervention cohort compared with placebo controls.
Lead researchers emphasized that targeting the gut-brain axis through intestinal microbial modulation provides clinical evidence for a novel and promising therapeutic strategy against chronic insomnia.
Variability in baseline microbial composition appears to contribute to observed treatment response heterogeneity, highlighting the necessity for further investigation into personalized microbiota-based insomnia therapies.

Summary

Clinical efficacy of an oral fecal microbiota transplantation (FMT) treatment protocol for adults diagnosed with chronic insomnia disorder. Chronic insomnia is a highly prevalent and burdensome condition with limited long-term treatment options. Given emerging evidence establishing the gut-brain axis as an important regulator of human sleep architecture, researchers conducted a multicenter, randomized, double-blind, placebo-controlled trial to investigate whether gut microbiome modulation following antibiotic pretreatment could improve objective and subjective sleep metrics.

During the study, adult participants received oral capsules containing healthy donor fecal microbes or placebo. Objective sleep parameters were quantitatively measured one month post-treatment using overnight polysomnography. The intervention group demonstrated statistically significant improvements in sleep efficiency and a marked reduction in wake after sleep onset relative to placebo controls, confirming enhanced objective sleep continuity.

Longitudinal assessment via patient-reported questionnaires demonstrated sustained therapeutic benefits over a extended follow-up period. Subjective sleep quality scores showed significant improvement from two to six months post-treatment in the FMT cohort compared with the placebo group. Analysis indicated that individual baseline microbial composition contributed to treatment response heterogeneity, highlighting the potential role of gut microbiota composition in therapeutic outcomes. These clinical findings demonstrate that targeting the intestinal microbiota represents a novel strategy for managing chronic insomnia disorder.

Link to the article: https://onlinelibrary.wiley.com/doi/10.1111/joim.70137

References

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., … Lu, L. (2026). Fecal microbiota transplantation‐based treatment protocol for chronic insomnia disorder: A randomized, double‐blind, placebo‐controlled trial. Journal of Internal Medicine, joim.70137. https://doi.org/10.1111/joim.70137