CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
fecal microbiota +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05917379
NCT05917379Phase 2Completed
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The Safety and Efficacy of Fecal Microbiota Transplantation in Patients With Chronic Insomnia Disorder

Peking University Sixth Hospital·interventional·Posted Jun 23, 2023·Updated Feb 27, 2026

In Brief

A Phase 2 clinical trial evaluating fecal microbiota, Placebo, and 1 other intervention for Insomnia Chronic and 5 related conditions. Completed, enrolled 80 participants across 7 sites.

Detailed Summary

This clinical trial aims to learn about the efficacy of fecal microbiota transplantation in patients with chronic insomnia disorder. The main question\[s\] it aims to answer is: • Effectiveness of the FMT oral capsule route for patients with chronic insomnia Participants in the intervention group will be given FMT by boral capsule pathway, and in the control group, they will be given the same appearance capsules containing starch. Researchers will compare the sleep status(PSQI and PSG)of the patients in both groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia Chronic, Fecal Microbiota Transplantation, Sleep Disorder, Depression, Anxiety, Cognitive Impairment
CountriesChina
CollaboratorsHefei Fourth People's Hospital/Anhui Mental Health Center, The Second Hospital of Anhui Medical University, First Affiliated Hospital of Chongqing Medical University, Henan Provincial Mental Hospital/The Second Affiliated Hospital of Xinxiang Medical University, The First Affiliated Hospital of Shanxi Medical University, Shandong First Medical University

Timeline

Phase 2CompletedFinished
202420252026
First PostedJun 23, 2023
Enrollment StartOct 8, 2023
Primary CompletionApr 10, 2025
Study CompletionJul 24, 2025
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.0 years ago

Interventions

fecal microbiotabiological

FMT utilizes stool from a healthy donor and puts them into capsules after processing

Placeboother

Starch into the same outlook capsule with fecal microbiota

synbioticsdietary

Lactobacillus Helveticas+ Bifidobacterial longum + inulin(3g/day)