NCT05917379

The Efficacy and Safty of FMT in Patients With CID

The Safety and Efficacy of Fecal Microbiota Transplantation in Patients With Chronic Insomnia Disorder

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Peking University Sixth Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia Chronic
• Fecal Microbiota Transplantation
• Sleep Disorder
• Depression
• Anxiety
• Cognitive Impairment

Interventions

Type	Name	Description
BIOLOGICAL	fecal microbiota	FMT utilizes stool from a healthy donor and puts them into capsules after processing
OTHER	Placebo	Starch into the same outlook capsule with fecal microbiota
DIETARY_SUPPLEMENT	synbiotics	Lactobacillus Helveticas+ Bifidobacterial longum + inulin(3g/day)

Timeline

• Start date: 2023-10-08
• Primary completion: 2025-04-10
• Completion: 2025-07-24
• First posted: 2023-06-23
• Last updated: 2026-02-27

Locations

7 sites across 1 country: China