The Efficacy and Safty of FMT in Patients With CID

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

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)

Sponsors & Collaborators

• Hefei Fourth People's Hospital/Anhui Mental Health Center

  collaborator UNKNOWN

• The Second Hospital of Anhui Medical University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Henan Provincial Mental Hospital/The Second Affiliated Hospital of Xinxiang Medical University

  collaborator UNKNOWN

• The First Affiliated Hospital of Shanxi Medical University

  collaborator OTHER

• Shandong First Medical University

  collaborator OTHER

• Peking University Sixth Hospital

  lead OTHER

Principal Investigators

• Lu · Peking University six hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-08

Primary Completion

2025-04-10

Completion

2025-07-24

Countries

• China

Study Locations