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Completed

NCT Number: NCT05917379

The Efficacy and Safty of FMT in Patients With CID

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Psychiatry, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Fecal microbiota

Biological

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

Other names: FMT

Placebo

Other

Starch into the same outlook capsule with fecal microbiota

synbiotics

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. Sleep onset latency (SL)

    Time frame: baseline and 1 month post FMT

    Based on polysomnography (mins)

  5. 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.

  6. 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.

  7. 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.

  8. Arousal index (ArI)

    Time frame: baseline and 1-month post FMT

    Based on polysomnography (events/h)

  9. Non-rapid eye movement sleep duration(NREM)

    Time frame: baseline and 1-month post FMT

    Based on polysomnography (mins)

  10. Rapid eye movement sleep duration(REM)

    Time frame: baseline and 1-month post FMT

    Based on polysomnography (mins)

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Other outcomes

  1. 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.

  2. 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.

  3. Multiplex cytokine analysis(pg/mL)

    Time frame: baseline and 1-month post FMT

    IL-1β, IL-6

  4. Ach levels(pmol/mL)

    Time frame: baseline and 1-month post FMT

    Automatic nervous system related factors

  5. NE levels(pg/mL)

    Time frame: baseline and 1-month post FMT

    Automatic nervous system related factors

Sponsors and collaborators

Lead sponsor

Peking University Sixth Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 23, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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