FMT Capsules in Treatment of Patients With Insomnia Clinical Research

Study Overview
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Brief Summary
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Objective: To investigate whether Fecal Microbiota Transplantation(FMT) can improve sleep in patients with insomnia, its effect on gut microbiota and its metabolites, and its effect on inflammatory factors, neurotransmitters and sex hormones in peripheral blood. Methods: The study needs to recruit 60 patients with insomnia and randomly divide them into FMT capsule treatment group or Placebo treatment group. The patients were followed up before the treatment and 4, 8, and 12 weeks after the treatment. The sleep status of the patients was assessed by Pittsburgh sleep quality index-PSQI, and the changes of gut microbiota and its metabolites were detected by Metagenomic sequencing and metabonomics analysis.The expression of cytokines, sex hormones and neurotransmitters in peripheral blood were detected by Elisa.

Detailed Description
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Insomnia is increasingly common in modern society. In recent years, more and more studies have shown that compared with healthy people, insomnia patients have changes in gut microbiota and its metabolites. At the same time, gut microbiota, as an important part of the gastrointestinal tract, can affect the stability of the body's internal environment through a variety of ways through the microbial-gut-brain axis, including the regulation of immune response. However, relevant studies at home and abroad mainly focus on sleep deprivation, while there are few reports on the intervention of gut microbiota in insomnia. The purpose of this study was to investigate whether Fecal Microbiota Transplantation(FMT) can improve sleep in patients with insomnia, its effect on gut microbiota and its metabolites,and its effect on inflammatory factors, neurotransmitters and sex hormones in peripheral blood. The study needs to recruit 60 patients with insomnia and randomly divide them into FMT capsule treatment group or Placebo treatment group. The patients were followed up before the treatment and 4, 8, and 12 weeks after the treatment. The sleep status of the patients was assessed by Pittsburgh sleep quality index-PSQI, and the changes of gut microbiota and its metabolites were detected by Metagenomic sequencing and metabonomics analysis.The expression of cytokines, sex hormones and neurotransmitters in peripheral blood were detected by Elisa.

Official Title
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Enterobacteria Capsules in Treatment of Patients With Insomnia Clinical Research on Effectiveness and Safety

Conditions
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Chronic Insomnia

Intervention / Treatment
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* Drug: FMT capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Men and women are not limited, the age is 18-70 years old; 2) The course of disease is more than 3 months, and the diagnosis is insomnia (refer to the diagnostic criteria of insomnia in the International Classification of Sleep Disorders Third Edition (ICSD3), and Pittsburgh sleep quality index-PSQI>15 points); 3) The vital signs are stable, the consciousness is clear, there is no communication and cognitive impairment, and can cooperate with the questionnaire; 4) Agree to participate in the research and sign the informed consent; 5) Able to receive follow-up examinations, follow-up examinations and collection of specimens on time. Exclusion Criteria: 1) The patients took probiotics or prebiotics products within 3 months before the research; 2) The patient took antibiotics within 3 months before the research; 3) The patient smokes heavily (≥10 cigarettes/day), or is dependent on alcohol, coffee, or strong tea; 4) The Patients rely on tube feeding; 5) The patient has a history of severe allergies; 6) The patient has severe organic disease; 7) The patient cannot cooperate to complete the study; 8) Pregnant or lactating women; 9) The patient has depression, anxiety, schizophrenia or other serious mental illness; 10) The Patients with insomnia due to physical diseases or mental disorders; 11) Other patients deemed unsuitable for inclusion by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 capsule treatment group<br>drugs use generic name: FMT capsule dosage form: capsule dosage, frequency: 16 capsules once a week duration: 4 weeks | Drug: FMT capsule<br>* Patients with insomnia need to take FMT capsules orally in an empty stomach in the morning, 16 capsules once a week, for 4 consecutive weeks<br>|
| Placebo Comparator: Placebo treatment group<br>drugs use generic name: Placebo dosage form:capsule dosage,frequency:16 capsules once a week duration:4 weeks | Drug: FMT capsule<br>* Patients with insomnia need to take FMT capsules orally in an empty stomach in the morning, 16 capsules once a week, for 4 consecutive weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSQI scale was used to assess sleep | Pittsburgh sleep quality index scale was used to assess sleep | FMT capsule/placebo treatment after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The metagenomic measure the types of gut microbiota | The metagenomic measure the types of gut microbiota | FMT capsule/placebo treatment after 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FMT, Insomnia