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We conducted a multicenter, randomized, double\u2010blind, placebo\u2010controlled trial to determine whether a fecal microbiota transplantation (FMT)\u2010based treatment protocol improves sleep outcomes in adults with chronic insomnia disorder.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Participants were randomly assigned 1:1 to receive short\u2010course antibiotic pretreatment followed by donor microbiota capsules (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a040) or placebo capsules without antibiotic pretreatment (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a040). Within each group, participants were further randomized to receive synbiotic supplementation or matched placebo for prespecified exploratory subgroup analyses. The primary outcome was polysomnography\u2010measured sleep efficiency (SE) at 1 month after treatment. Secondary outcomes included other polysomnographic parameters, patient\u2010reported sleep outcomes, and safety; microbiota analyses were exploratory.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Compared with placebo, the FMT\u2010based treatment protocol improved SE (adjusted between\u2010group difference, 13.9 percentage points; 95% CI 7.29\u201320.41;\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.003) and reduced wake after sleep onset. Synbiotic assignment did not suggest meaningful differences in SE. Insomnia Severity Index and Pittsburgh Sleep Quality Index scores showed sustained improvement from 2 to 6 months. Treatment was well tolerated, with mild, self\u2010limited adverse events and no serious adverse events. The intervention increased microbial richness and diversity and altered community structure; responders and non\u2010responders showed similar posttreatment\n                      <jats:italic>\u03b2<\/jats:italic>\n                      \u2010diversity change but differed in baseline microbiota composition.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In adults with chronic insomnia disorder, an FMT\u2010based treatment protocol incorporating antibiotic pretreatment improved objective sleep continuity and sustained subjective insomnia outcomes. Baseline microbial composition may contribute to treatment heterogeneity and merits further investigation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/joim.70137","type":"journal-article","created":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T07:01:40Z","timestamp":1784703700000},"page":"623-641","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Fecal microbiota transplantation\u2010based treatment protocol for chronic insomnia disorder: A randomized, double\u2010blind, placebo\u2010controlled trial"],"prefix":"10.1111","volume":"300","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5825-6541","authenticated-orcid":false,"given":"Teng","family":"Gao","sequence":"first","affiliation":[{"name":"Peking University Sixth Hospital, Peking University Institute of Mental Health Beijing 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