Clinical trial NCT05427331: FMT Capsules in Treatment of Patients With Insomnia Clinical Research
Official title: Enterobacteria Capsules in Treatment of Patients With Insomnia Clinical Research on Effectiveness and Safety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Insomnia
Keywords: FMT
Insomnia
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PSQI scale was used to assess sleep
timeFrame: FMT capsule/placebo treatment after 4 weeks
Secondary outcomes:
measure: The metagenomic measure the types of gut microbiota
timeFrame: FMT capsule/placebo treatment after 4 weeks
Other outcomes:
measure: The concentration of serotonin
timeFrame: FMT capsule/placebo treatment after 4 weeks
measure: The concentration of norepinephrine
timeFrame: FMT capsule/placebo treatment after 4 weeks
measure: The concentration of dopamine
timeFrame: FMT capsule/placebo treatment after 4 weeks
measure: The concentration of ϒ- aminobutyric acid
timeFrame: FMT capsule/placebo treatment after 4 weeks
measure: The concentration of melatonin
timeFrame: FMT capsule/placebo treatment after 4 weeks
measure: The concentration of interleukin-6
timeFrame: FMT capsule/placebo treatment after 4 weeks
measure: The concentration of interleukin-1 β
timeFrame: FMT capsule/placebo treatment after 4 weeks
measure: The concentration of tumor Necrosis Factor -α
timeFrame: FMT capsule/placebo treatment after 4 weeks
measure: The concentration of interleukin-10
timeFrame: FMT capsule/placebo treatment after 4 weeks
measure: The concentration of follicle-stimulating hormone
timeFrame: FMT capsule/placebo treatment after 4 weeks
measure: The concentration of estradiol
timeFrame: FMT capsule/placebo treatment after 4 weeks
Locations:
city: Chongqing
country: China
facility: Third Military Medical University Daping Hospital
state: Chongqing
Study officials:
affiliation: Third Military Medical University
name: Yanling Wei
role: STUDY_DIRECTOR
References: