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Insomnia ChronicPhase 1/2NCT05917379

The Efficacy and Safty of FMT in Patients With CID

A Phase 1/2 study testing fecal microbiota and synbiotics in people with Insomnia Chronic and Fecal Microbiota Transplantation, run by Peking University Sixth Hospital at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
fecal microbiota and synbiotics
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
7 sitesChina
Study dates
8 Oct 2023to 24 Jul 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Peking University Six Hospital

    Beijing, Beijing Municipality, 100191

  • Department of Psychiatry, The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

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

    Hefei, Anhui, 230022

  • Department of Psychiatry, The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Institute of Brain Science and Brain-inspired Research, Shandong First Medical University and Shandong Academy of Medical Sciences

    Jinan, Shandong, 250117

  • Department of Psychiatry, First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Department of Physical Therapy, The Second Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453002

Other trials in China

About this study

Official title: 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.

Being tested
fecal microbiota, Placebo, synbiotics
Medical subject headings
Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Depression, Anxiety Disorders, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fecal microbiotaBiological

    Also called FMT

    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 supplement

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

Study groups in NCT05917379
Study groupRoleWhat they receive
FMTExperimentalInvestigators 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.
Receives: Biological: fecal microbiota; Dietary Supplement: synbiotics
Non-FMTPlacebo comparatorInvestigators 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.
Receives: Other: Placebo; Dietary Supplement: synbiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep efficiency

    (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

    Measured: 1 month post FMT

Secondary outcomes (14)

  1. Pittsburgh Sleep Quality Index，PSQI

    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

    Measured: baseline and 1-, 2-, 3-, 6- months post FMT

  2. Insomnia Severity Index，ISI

    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.

    Measured: baseline and 1-, 2-, 3-, 6- months post FMT

  3. Bray-Curtis dissimilarity

    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

    Measured: baseline and 1-month post FMT

  4. Sleep onset latency (SL)

    Based on polysomnography (mins)

    Measured: baseline and 1 month post FMT

  5. Self-Rating Anxiety Scale (SAS)

    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.

    Measured: baseline and 1-, 2-, 3-, 6- months post FMT

  6. Self-Rating Depression Scale (SDS)

    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.

    Measured: baseline and 1-, 2-, 3-, 6-months post FMT

  7. Gastrointestinal Symptom Rating Scale，GSRS

    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.

    Measured: baseline and 1-, 2-, 3-, 6-months post FMT

  8. Arousal index (ArI)

    Based on polysomnography (events/h)

    Measured: baseline and 1-month post FMT

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

    Based on polysomnography (mins)

    Measured: baseline and 1-month post FMT

  10. Rapid eye movement sleep duration(REM)

    Based on polysomnography (mins)

    Measured: baseline and 1-month post FMT

  11. Observed OTUs

    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.

    Measured: baseline and 1-month post FMT

  12. Shannon Diversity Index

    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.

    Measured: baseline and 1-month post FMT

  13. Simpson Diversity Index

    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.

    Measured: baseline and 1-month post FMT

  14. Chao1 Richness Estimator

    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.

    Measured: baseline and 1-month post FMT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start8 Oct 2023
  3. Primary completion10 Apr 2025
  4. Study completion24 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05917379
Sponsor's protocol ID
PekingUSH 20241218
Status last verified
Feb 2026
First submitted
25 May 2023
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After the publication of the research results, the data will be shared on this website and relevant journal platforms

Publications

  • Wang Z, Wang Z, Lu T, Chen W, Yan W, Yuan K, Shi L, Liu X, Zhou X, Shi J, Vitiello MV, Han Y, Lu L. The microbiota-gut-brain axis in sleep disorders. Sleep Med Rev. 2022 Oct;65:101691. doi: 10.1016/j.smrv.2022.101691. Epub 2022 Aug 31.

    PubMed 36099873

  • Wang X, Wang Z, Cao J, Dong Y, Chen Y. Gut microbiota-derived metabolites mediate the neuroprotective effect of melatonin in cognitive impairment induced by sleep deprivation. Microbiome. 2023 Jan 31;11(1):17. doi: 10.1186/s40168-022-01452-3.

    PubMed 36721179

  • Perlis ML, Posner D, Riemann D, Bastien CH, Teel J, Thase M. Insomnia. Lancet. 2022 Sep 24;400(10357):1047-1060. doi: 10.1016/S0140-6736(22)00879-0. Epub 2022 Sep 14.

    PubMed 36115372

  • Li Y, Zhang B, Zhou Y, Wang D, Liu X, Li L, Wang T, Zhang Y, Jiang M, Tang H, Amsel LV, Fan F, Hoven CW. Gut Microbiota Changes and Their Relationship with Inflammation in Patients with Acute and Chronic Insomnia. Nat Sci Sleep. 2020 Nov 5;12:895-905. doi: 10.2147/NSS.S271927. eCollection 2020.

    PubMed 33177907

  • Haifer C, Kelly CR, Paramsothy S, Andresen D, Papanicolas LE, McKew GL, Borody TJ, Kamm M, Costello SP, Andrews JM, Begun J, Chan HT, Connor S, Ghaly S, Johnson PD, Lemberg DA, Paramsothy R, Redmond A, Sheorey H, van der Poorten D, Leong RW. Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice. Gut. 2020 May;69(5):801-810. doi: 10.1136/gutjnl-2019-320260. Epub 2020 Feb 11.

    PubMed 32047093

  • Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.

    PubMed 28087657

  • Cammarota G, Ianiro G, Kelly CR, Mullish BH, Allegretti JR, Kassam Z, Putignani L, Fischer M, Keller JJ, Costello SP, Sokol H, Kump P, Satokari R, Kahn SA, Kao D, Arkkila P, Kuijper EJ, Vehreschild MJG, Pintus C, Lopetuso L, Masucci L, Scaldaferri F, Terveer EM, Nieuwdorp M, Lopez-Sanroman A, Kupcinskas J, Hart A, Tilg H, Gasbarrini A. International consensus conference on stool banking for faecal microbiota transplantation in clinical practice. Gut. 2019 Dec;68(12):2111-2121. doi: 10.1136/gutjnl-2019-319548. Epub 2019 Sep 28.

    PubMed 31563878

  • Gao T, Zheng M, Geng F, Fu Y, Yang Y, Li X, Wang Y, Zhu D, Wang Z, Lu L. Autonomic modulation following fecal microbiota transplantation in chronic insomnia. Postgrad Med. 2026 May;138(4):417-429. doi: 10.1080/00325481.2026.2664261. Epub 2026 Apr 23.

    PubMed 42026772

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing fecal microbiota and synbiotics in people with Insomnia Chronic and Fecal Microbiota Transplantation, run by Peking University Sixth Hospital at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep efficiency (time frame: 1 month post FMT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05917379, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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