Chronic Insomnia
Conditions
Keywords
FMT, Insomnia
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.
Interventions
DRUGFMT capsule
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
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSQI scale was used to assess sleep | FMT capsule/placebo treatment after 4 weeks | Pittsburgh sleep quality index scale was used to assess sleep |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The metagenomic measure the types of gut microbiota | FMT capsule/placebo treatment after 4 weeks | The metagenomic measure the types of gut microbiota |
Other
| Measure | Time frame | Description |
|---|---|---|
| The concentration of dopamine | FMT capsule/placebo treatment after 4 weeks | The concentration of dopamine by ELISA |
| The concentration of ϒ- aminobutyric acid | FMT capsule/placebo treatment after 4 weeks | The concentration of ϒ- aminobutyric acid by ELISA |
| The concentration of melatonin | FMT capsule/placebo treatment after 4 weeks | The concentration of melatonin by ELISA |
| The concentration of interleukin-6 | FMT capsule/placebo treatment after 4 weeks | The concentration of interleukin-6 by ELISA |
| The concentration of serotonin | FMT capsule/placebo treatment after 4 weeks | The concentration of serotonin by ELISA |
| The concentration of tumor Necrosis Factor -α | FMT capsule/placebo treatment after 4 weeks | The concentration of tumor Necrosis Factor -α by ELISA |
| The concentration of interleukin-10 | FMT capsule/placebo treatment after 4 weeks | The concentration of interleukin-10 by ELISA |
| The concentration of follicle-stimulating hormone | FMT capsule/placebo treatment after 4 weeks | The concentration of follicle-stimulating hormone by ELISA |
| The concentration of estradiol | FMT capsule/placebo treatment after 4 weeks | The concentration of estradiol by ELISA |
| The concentration of interleukin-1 β | FMT capsule/placebo treatment after 4 weeks | The concentration of interleukin-1 β by ELISA |
| The concentration of norepinephrine | FMT capsule/placebo treatment after 4 weeks | The concentration of norepinephrine by ELISA |
Countries
China
Contacts
Primary ContactYanling Wei, MD
Outcome results
None listed