The Efficacy and Safty of FMT in Patients With CID

February 26, 2026 updated by: Gao Teng, Peking University Sixth Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Donors management and FMT oral capsule used here will be prepared according to the "International consensus conference on Stool Banking for fecal microbiota transplantation in clinical practice"

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • Hefei Fourth People's Hospital/Anhui Mental Health Center
      • Hefei, Anhui, China, 230601
        • Department of Psychiatry, The Second Affiliated Hospital of Anhui Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Six Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Department of Psychiatry, The First Affiliated Hospital of Chongqing Medical University
    • Henan
      • Xinxiang, Henan, China, 453002
        • Department of Physical Therapy, The Second Affiliated Hospital of Xinxiang Medical University
    • Shandong
      • Jinan, Shandong, China, 250117
        • Institute of Brain Science and Brain-inspired Research, Shandong First Medical University and Shandong Academy of Medical Sciences
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Department of Psychiatry, First Hospital of Shanxi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosed CID by DSM-5
  2. 18-60 years old24
  3. Body Mass Index (BMI) within the range of 18-24 kg/m²
  4. No other pharmacologic treatment in the last month or at the stable maintenance stage (stable dose for more than two months)

Exclusion Criteria:

  1. Currently pregnant, planning pregnancy shortly, or breastfeeding
  2. Undergoing or recently received immunosuppressive therapy, or severe immunosuppression (neutrophil count <1500 cells/mm³, lymphocyte count <500 cells/mm³)
  3. Diagnosis of one or more specific gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, gastrointestinal tumors, pseudomembranous enteritis, gastrointestinal bleeding, enterocutaneous fistula, etc.)
  4. Diseases with significant correlations to gut microbiota include Type 2 Diabetes, thyroid disorders, migraines, and autoimmune diseases
  5. Ex-/intraintestinal organ infection
  6. Abnormal liver or kidney function
  7. Faecal occult blood test (+)
  8. Suffering from chronic pain, restless leg syndrome, obstructive sleep apnea, or thyroid disorders.
  9. Central nervous system disorders (e.g., epilepsy, Parkinson's disease, history of traumatic brain injury, cerebrovascular diseases, etc.)
  10. Current smokers or alcohol drinkers
  11. History of food or antibiotic allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FMT
Investigators have 2 subgroups here, pure Fecal microbiota transplantation-F: Fecal microbiota capsules(0.75g stool/capsule) (60 capsules), within 3 days, another 20 fecal microbiota capsules(0.75g stool/capsule) at week 2. Additionally, they will take placebo B for 45 days from the beginning; Fecal microbiota transplantation+synbiotics-M: Fecal microbiota capsules(0.75g stool/capsule) (60 capsules), within 3 days, another 20 fecal microbiota capsules(0.75g stool/capsule) at week 2. Additionally, they will take synbiotics (Lactobacillus Helveticus Bifidobacterium longum + inulin) (3g/day) for 45 days from the beginning.
Biological: fecal microbiota
FMT utilizes stool from a healthy donor and puts them into capsules after processing
Other Names:
  • FMT
Dietary supplement: synbiotics
Lactobacillus Helveticas+ Bifidobacterial longum + inulin(3g/day)
Placebo Comparator: Non-FMT
Investigators have 2 subgroups here, synbiotics control-S: PlaceboA capsules (60 capsules), within 3 days, another 20 placeboA capsules(0.75g stool/capsule) at week 2. Additionally, they will take synbiotics (Lactobacillus Helveticas+ Bifidobacterial longum + inulin) (3g/day) for 45 days from the beginning; Double Placebo-P: PlaceboA capsules (60 capsules), within 3 days, another 20 placeboA capsules(0.75g stool/capsule) at week 2. Additionally, they will take placebo B for 45 days from the beginning.
Other: Placebo
Starch into the same outlook capsule with fecal microbiota
Dietary supplement: synbiotics
Lactobacillus Helveticas+ Bifidobacterial longum + inulin(3g/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep efficiency
Time Frame: 1 month post FMT
(Total Time Asleep / Total Time in Bed×100%) of CID patients will be objectively ，assessed using PSG at week 4 post-FMT (compared to baseline). Additionally, subjective measures including PSQI and ISI scores will be included
1 month post FMT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index，PSQI
Time Frame: baseline and 1-, 2-, 3-, 6- months post FMT
The PSQI was used to assess the sleep quality of the participants in the last 1 month. It consists of 19 self-assessments and 5 self-assessment items, of which the 19th self-assessment item and 5 self-assessment items do not participate in the scoring. The 18 items formed 7 components, and each component was scored according to 0-3 levels. The cumulative score of PSQI total score ranged from 0 to 2 l. The higher the score, the worse the sleep quality
baseline and 1-, 2-, 3-, 6- months post FMT
Insomnia Severity Index，ISI
Time Frame: baseline and 1-, 2-, 3-, 6- months post FMT
ISI is a commonly used insomnia severity scale used to assess the extent and impact of individual insomnia in the past two weeks. The ISI consists of seven items, and individuals need to choose the answer best suitable for their condition on each item, and then aggregate the scores of all items to get the total score. The total score ranged from 0 to 28, with higher scores indicating higher insomnia severity. Each item has four answer options, used to describe the frequency of insomnia, severity and effects on the individual.
baseline and 1-, 2-, 3-, 6- months post FMT
Bray-Curtis dissimilarity
Time Frame: baseline and 1-month post FMT
Bray-Curtis dissimilarity is a beta diversity metric used to quantify differences in microbial community composition between two time points. A higher dissimilarity score indicates greater divergence in taxonomic profiles. This outcome measures the change in gut microbiota structure from baseline to 1-month after fecal microbiota transplantation (FMT), serving as an index of engraftment and microbial shift
baseline and 1-month post FMT
Sleep onset latency (SL)
Time Frame: baseline and 1 month post FMT
Based on polysomnography (mins)
baseline and 1 month post FMT
Self-Rating Anxiety Scale (SAS)
Time Frame: baseline and 1-, 2-, 3-, 6- months post FMT
Participants need to according to the past a period of time (usually in the past week or two weeks), choose a most accord with their feelings answer options, usually expressed by the following level: no or little time (1), part of the time (2 points), quite a large amount of time (3 points), most or all of the time (4 points). An initial assessment of individual anxiety was possible by calculating the total score.
baseline and 1-, 2-, 3-, 6- months post FMT
Self-Rating Depression Scale (SDS)
Time Frame: baseline and 1-, 2-, 3-, 6-months post FMT
It usually contains 20 topics and is widely used in research and clinical practice. Participants need to according to the past a period of time (usually in the past week or two weeks), choose a most accord with their feelings answer options, usually expressed by the following level: no or little time (1), part of the time (2), quite a large amount of time (3), most or all of the time (4). The total raw score ranges from 20 to 80, and is typically converted to a standard score by multiplying by 1.25 (range: 25 to 100), with higher scores indicating greater severity of depression.
baseline and 1-, 2-, 3-, 6-months post FMT
Gastrointestinal Symptom Rating Scale，GSRS
Time Frame: baseline and 1-, 2-, 3-, 6-months post FMT
The GSRS includes 15 questions about gastrointestinal symptoms covering a range of symptoms including abdominal pain, flatulence, nausea, vomiting, loss of appetite, etc.The score rang from 16-112, the less the better.
baseline and 1-, 2-, 3-, 6-months post FMT
Arousal index (ArI)
Time Frame: baseline and 1-month post FMT
Based on polysomnography (events/h)
baseline and 1-month post FMT
Non-rapid eye movement sleep duration(NREM)
Time Frame: baseline and 1-month post FMT
Based on polysomnography (mins)
baseline and 1-month post FMT
Rapid eye movement sleep duration(REM)
Time Frame: baseline and 1-month post FMT
Based on polysomnography (mins)
baseline and 1-month post FMT
Observed OTUs
Time Frame: baseline and 1-month post FMT
Observed OTUs (Operational Taxonomic Units) represent the count of unique taxa identified in a sample, reflecting species richness. This outcome measures the number of observed OTUs in fecal samples at baseline and 1-month post-FMT, indicating changes in microbial richness following intervention.
baseline and 1-month post FMT
Shannon Diversity Index
Time Frame: baseline and 1-month post FMT
The Shannon index is a commonly used α-diversity metric that accounts for both richness and evenness in microbial communities. Higher values reflect greater diversity. This outcome evaluates within-sample microbial diversity before and after FMT.
baseline and 1-month post FMT
Simpson Diversity Index
Time Frame: baseline and 1-month post FMT
The Simpson index measures the probability that two randomly selected individuals in a sample belong to the same species. It is sensitive to dominant taxa. This outcome assesses within-sample microbial diversity changes induced by FMT.
baseline and 1-month post FMT
Chao1 Richness Estimator
Time Frame: baseline and 1-month post FMT
The Chao1 index estimates microbial species richness by accounting for the number of rare taxa (singletons and doubletons). It provides a more robust estimate of total richness compared to observed OTUs. This outcome evaluates the estimated richness change after FMT.
baseline and 1-month post FMT

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiplex cytokine analysis(pg/mL)
Time Frame: baseline and 1-month post FMT
IL-1β, IL-6
baseline and 1-month post FMT
Repeatable Battery for the Assessment of Neuropsychological Status，RBANS
Time Frame: baseline and 3-month post FMT

The RBANS consists of 12 subtests that assess five cognitive domains: immediate memory, visuospatial/constructional ability, language, attention, and delayed memory. It yields a Total Scale Index Score with a mean of 100 and a standard deviation of 15, where higher scores indicate better cognitive performance.

RBANS is widely used in clinical and research settings to evaluate cognitive impairment, monitor disease progression, and assess treatment effects. Individual scores can be compared with normative data stratified by age and education level.
baseline and 3-month post FMT
Heart Rate Variability ,HRV
Time Frame: baseline and 1 months post FMT
Heart rate variability is where the amount of time between your heartbeats fluctuates slightly. Even though these fluctuations are undetectable except with specialized devices, they can still indicate current or future health problems, including heart conditions and mental health issues like anxiety and depression.
baseline and 1 months post FMT
Ach levels（pmol/mL）
Time Frame: baseline and 1-month post FMT
Automatic nervous system related factors
baseline and 1-month post FMT
NE levels（pg/mL）
Time Frame: baseline and 1-month post FMT
Automatic nervous system related factors
baseline and 1-month post FMT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Sixth Hospital

Collaborators

The First Affiliated Hospital of Shanxi Medical University
First Affiliated Hospital of Chongqing Medical University
The Second Hospital of Anhui Medical University
Shandong First Medical University
Hefei Fourth People's Hospital/Anhui Mental Health Center
Henan Provincial Mental Hospital/The Second Affiliated Hospital of Xinxiang Medical University

Investigators

  • Study Director: Lu, Peking University Six Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2023

Primary Completion (Actual)

April 10, 2025

Study Completion (Actual)

July 24, 2025

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUSH 20241218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the publication of the research results, the data will be shared on this website and relevant journal platforms

IPD Sharing Time Frame

1st December 2025

IPD Sharing Access Criteria

Open assess

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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