The Efficacy and Safty of FMT in Patients With CID

NCT05917379 | Completed Phase 1 DMC

• 1 other identifier: PekingUSH 20241218
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (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

  1 month post FMT

Secondary Outcomes (14)

• Pittsburgh Sleep Quality Index，PSQI

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

• Insomnia Severity Index，ISI

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

• Bray-Curtis dissimilarity

  baseline and 1-month post FMT

• Sleep onset latency (SL)

  baseline and 1 month post FMT

• Self-Rating Anxiety Scale (SAS)

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

Other Outcomes (5)

• Repeatable Battery for the Assessment of Neuropsychological Status，RBANS

  baseline and 3-month post FMT

• Heart Rate Variability ,HRV

  baseline and 1 months post FMT

• Multiplex cytokine analysis(pg/mL)

  baseline and 1-month post FMT

Study Arms (2)

FMT

EXPERIMENTAL

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; Dietary Supplement: synbiotics

Non-FMT

PLACEBO COMPARATOR

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; Dietary Supplement: synbiotics

Interventions

fecal microbiota BIOLOGICAL

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

Also known as: FMT

FMT

Placebo OTHER

Starch into the same outlook capsule with fecal microbiota

Non-FMT

synbiotics DIETARY_SUPPLEMENT

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

FMT; Non-FMT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed CID by DSM-5
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (7)

Hefei Fourth People's Hospital/Anhui Mental Health Center

Hefei, Anhui, 230022, China

Location

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

Hefei, Anhui, 230601, China

Location

Peking University Six Hospital

Beijing, Beijing Municipality, 100191, China

Location

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

Chongqing, Chongqing Municipality, 400016, China

Location

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

Xinxiang, Henan, 453002, China

Location

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

Jinan, Shandong, 250117, China

Location

Department of Psychiatry, First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Related Publications (7)

• 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.

  PMID: 36099873 BACKGROUND

• 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.

  PMID: 36721179 BACKGROUND

• 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.

  PMID: 36115372 BACKGROUND

• 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.

  PMID: 33177907 BACKGROUND

• 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.

  PMID: 32047093 BACKGROUND

• 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.

  PMID: 28087657 BACKGROUND

• 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.

  PMID: 31563878 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Depression; Anxiety Disorders; Cognitive Dysfunction

Interventions

Fecal Microbiota Transplantation; Synbiotics

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Officials

• Lu

  Peking University six hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking University

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 23, 2023
• Study Start: October 8, 2023
• Primary Completion: April 10, 2025
• Study Completion: July 24, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1st December 2025
• Access Criteria: Open assess

Locations

CN (7)