The Safety and Efficacy of FMT in Patients With CID Transplantation in Patients With Chronic Insomnia Disorder
Study Details
Study Description
Brief Summary
The goal of this clinical trial is to learn about The safety and efficacy of fecal microbiota transplantation in patients with chronic insomnia disorder. The main question[s] it aims to answer are:
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Safety of the FMT oral capsule pathway in the clinical treatment of chronic insomnia
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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 will be given the same appearance capsules containing vitamins.
Researchers will compare the sleep status(PSQI and PSG)of the patients in both groups.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FMT+Synbiotics Fecal microbiota capsules(0.75g stool/capsule) (10/day), for 3 days, meanwhile synbiotics(2g/day) for 14 days, another 15 fecal microbiota capsules(0.75g stool/capsule) at week 2 |
Biological: fecal microbiota
FMT utilizing stool from healthy donor
|
| Placebo Comparator: Placebo A +Placebo B Placebo A-capsules 10/day, for 3 days, meanwhile placebo B-vitamin C (2g/day) for 14 days, another 15 Placebo A at week 2 |
Biological: fecal microbiota
FMT utilizing stool from healthy donor
|
| Active Comparator: FMT + Placebo B Fecal microbiota capsules (0.75g stool/capsule)(10/day), for 3 days, meanwhile placebo vitamin C (2g/day) for 14 days, another 15 fecal microbiota capsules(0.75g stool/capsule) at week 2 |
Biological: fecal microbiota
FMT utilizing stool from healthy donor
|
| Active Comparator: Placebo A+Synbiotics Placebo capsules 10/day, for 3 days, meanwhile synbiotics(2g/day) for 14 days, another 15 Placebo A at week 2 |
Biological: fecal microbiota
FMT utilizing stool from healthy donor
|
Outcome Measures
Primary Outcome Measures
- PSQI [6 weeks after intervention]
The Pittsburgh Sleep Quality Index was used to assess the sleep quality of the participants in the last 1 month
- PSG [6 weeks after intervention]
Polysomnography was used to assess sleep latency,sleep duration in each period,total sleep time and sleep efficiency
- 16sRNA [6 weeks after intervention]
Feces were tested at 16S rRNA for the Alpha diversity indicator (alpha/beta diversity)
- Safety and Tolerability [6 week after intervention]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary Outcome Measures
- multiple cytokines and stress level [6 weeks after intervention]
Blood samples were performed for IL-6、IL-15、IL-17、GM-CSF、TNFα、IL-4、IL-10、IL-14、 cortisol; Urine sample for NE level of 24 hours
- PSQI [10、14 weeks and 6、12 months after intervention]
The Pittsburgh Sleep Quality Index was used to assess the sleep quality of the participants in the last 1 month
- PSG [10、14 weeks after intervention]
Polysomnography was used to assess sleep latency,sleep duration in each period,total sleep time and sleep efficiency
- 16sRNA [10、14 weeks and 6、12 months after intervention]
Feces were tested at 16S rRNA for the Alpha diversity indicator(alpha/beta diversity)
- SDS [6、10、14 weeks and 6、12 months after intervention]
Self-Rating Depression Scale(SDS)，depression severity = cumulative score of each item / 80. Results: no depression was found in patients below 0.5, mild to mild depression in 0.5, moderate to severe depression in 0.6, and severe depression in patients above 0.7.
- SAS [6、10、14 weeks and 6、12 months after intervention]
Self-Rating Anxiety Scale（SAS），The score of 20 items is added to get the coarse score (X). After the formula conversion, that is, after the rough score is multiplied by 1.25, the integer part is taken, and the standard score (Y) is obtained.The cut-off value of SAS standard deviation was 50 points, of which 50-59 points were mild anxiety, 60-69 points were moderate anxiety, and 69 points were severe anxiety.
- cognitive founction [14 weeks and12 months after intervention]
Montreal Cognitive Assessment(MoCA) score(0-30),higher scores means better cognitive function
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinical diagnosis of chronic insomnia disorder
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18 and ≤65 years old
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Must be able to swallow tablets and capsules
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Volunteer for the survey and sign the consent form
Exclusion Criteria:
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Current pregnancy or planned to be pregnant or breastfeeding in the near future
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Severe immunosuppression (neutrophils <1500 / mm3, lymphocytes <500 / mm3)
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Infective diseases that must use broad-spectrum antibiotics
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One or more clearly diagnosed intestinal diseases (Crohn's disease, ulcerative colitis, intestinal tumor, pseudomembranous enteritis, severe gastrointestinal bleeding, high-flow intestinal fistula)
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Fecal occult blood (+)
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Chronic pain
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Restrestless syndrome
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Obstructive sleep apnea syndrome
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Food allergy.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking University Sixth Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- PekingUSH 20230518