The Safety and Efficacy of FMT in Patients With CID Transplantation in Patients With Chronic Insomnia Disorder

Study Overview
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Brief Summary
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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: Safety of the FMT oral capsule pathway in the clinical treatment of chronic insomnia 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.

Detailed Description
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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

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

Conditions
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Insomnia Chronic, Fecal Microbiota Transplantation, Sleep Disorder, Depression, Anxiety, Cognitive Impairment

Intervention / Treatment
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* Biological: fecal microbiota


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of chronic insomnia disorder 18 and ≤65 years old Must be able to swallow tablets and capsules Volunteer for the survey and sign the consent form Exclusion Criteria: Current pregnancy or planned to be pregnant or breastfeeding in the near future Severe immunosuppression (neutrophils <1500 / mm3, lymphocytes <500 / mm3) Infective diseases that must use broad-spectrum antibiotics One or more clearly diagnosed intestinal diseases (Crohn's disease, ulcerative colitis, intestinal tumor, pseudomembranous enteritis, severe gastrointestinal bleeding, high-flow intestinal fistula) Fecal occult blood (+) Chronic pain Restrestless syndrome Obstructive sleep apnea syndrome Food allergy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT+Synbiotics<br>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<br>* FMT utilizing stool from healthy donor<br>|
| Placebo Comparator: Placebo A +Placebo B<br>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<br>* FMT utilizing stool from healthy donor<br>|
| Active Comparator: FMT + Placebo B<br>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<br>* FMT utilizing stool from healthy donor<br>|
| Active Comparator: Placebo A+Synbiotics<br>Placebo capsules 10/day, for 3 days, meanwhile synbiotics(2g/day) for 14 days, another 15 Placebo A at week 2 | Biological: fecal microbiota<br>* FMT utilizing stool from healthy donor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSQI | The Pittsburgh Sleep Quality Index was used to assess the sleep quality of the participants in the last 1 month | 6 weeks after intervention | 
| PSG | Polysomnography was used to assess sleep latency,sleep duration in each period,total sleep time and sleep efficiency | 6 weeks after intervention | 
| 16sRNA | Feces were tested at 16S rRNA for the Alpha diversity indicator (alpha/beta diversity) | 6 weeks after intervention | 
| Safety and Tolerability | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 6 week after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| multiple cytokines and stress level | 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 | 6 weeks after intervention | 
| PSQI | The Pittsburgh Sleep Quality Index was used to assess the sleep quality of the participants in the last 1 month | 10、14 weeks and 6、12 months after intervention | 
| PSG | Polysomnography was used to assess sleep latency,sleep duration in each period,total sleep time and sleep efficiency | 10、14 weeks after intervention | 
| 16sRNA | Feces were tested at 16S rRNA for the Alpha diversity indicator(alpha/beta diversity) | 10、14 weeks and 6、12 months after intervention | 
| SDS | 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. | 6、10、14 weeks and 6、12 months after intervention | 
| SAS | 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. | 6、10、14 weeks and 6、12 months after intervention | 
| cognitive founction | Montreal Cognitive Assessment(MoCA) score(0-30),higher scores means better cognitive function | 14 weeks and12 months after intervention |