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| Name | Class |
|---|---|
| Hefei Fourth People's Hospital/Anhui Mental Health Center | UNKNOWN |
| The Second Hospital of Anhui Medical University | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fecal microbiota | Biological | FMT utilizes stool from a healthy donor and puts them into capsules after processing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Repeatable Battery for the Assessment of Neuropsychological Status，RBANS | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lu | Peking University six hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hefei Fourth People's Hospital/Anhui Mental Health Center | Hefei | Anhui | 230022 | China | ||
| Department of Psychiatry, The Second Affiliated Hospital of Anhui Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36099873 | Background | 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. | |
| 36721179 | 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. |
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After the publication of the research results, the data will be shared on this website and relevant journal platforms
1st December 2025
Open assess
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012893 | Sleep Wake Disorders |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D058616 | Synbiotics |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
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| Henan Provincial Mental Hospital/The Second Affiliated Hospital of Xinxiang Medical University | UNKNOWN |
| The First Affiliated Hospital of Shanxi Medical University | OTHER |
| Shandong First Medical University | OTHER |
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| Placebo | Other | Starch into the same outlook capsule with fecal microbiota |
|
| synbiotics | Dietary Supplement | Lactobacillus Helveticas+ Bifidobacterial longum + inulin(3g/day) |
|
| baseline and 1-, 2-, 3-, 6- months post FMT |
| 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. | baseline and 1-, 2-, 3-, 6- months post FMT |
| 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 | baseline and 1-month post FMT |
| Sleep onset latency (SL) | Based on polysomnography (mins) | baseline and 1 month post FMT |
| 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. | baseline and 1-, 2-, 3-, 6- months post FMT |
| 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. | baseline and 1-, 2-, 3-, 6-months post FMT |
| 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. | baseline and 1-, 2-, 3-, 6-months post FMT |
| Arousal index (ArI) | Based on polysomnography (events/h) | baseline and 1-month post FMT |
| Non-rapid eye movement sleep duration(NREM) | Based on polysomnography (mins) | baseline and 1-month post FMT |
| Rapid eye movement sleep duration(REM) | Based on polysomnography (mins) | baseline and 1-month post FMT |
| 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. | baseline and 1-month post FMT |
| 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. | baseline and 1-month post FMT |
| 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. | baseline and 1-month post FMT |
| 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. | baseline and 1-month post FMT |
| baseline and 3-month post FMT |
| Heart Rate Variability ,HRV | 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 |
| Multiplex cytokine analysis(pg/mL) | IL-1β, IL-6 | baseline and 1-month post FMT |
| Ach levels（pmol/mL） | Automatic nervous system related factors | baseline and 1-month post FMT |
| NE levels（pg/mL） | Automatic nervous system related factors | baseline and 1-month post FMT |
| Hefei |
| Anhui |
| 230601 |
| China |
| Peking University Six Hospital | Beijing | Beijing Municipality | 100191 | China |
| Department of Psychiatry, The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
| Department of Physical Therapy, The Second Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | 453002 | China |
| Institute of Brain Science and Brain-inspired Research, Shandong First Medical University and Shandong Academy of Medical Sciences | Jinan | Shandong | 250117 | China |
| Department of Psychiatry, First Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| 36115372 | 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. |
| 33177907 | 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. |
| 32047093 | 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. |
| 28087657 | 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. |
| 31563878 | 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. |
| 42026772 | Derived | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D005502 |
| Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |