FMT Capsules in Treatment of Patients With Insomnia Clinical Research

Chronic Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05427331
• Other study ID #: FMT-202201
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Third Military Medical University
• Contact: Yanling Wei, MD
• Phone: 15310354666
• Email: lingzi016[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• FMT 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

Locations

Country	Name	City	State
China	Third Military Medical University Daping Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The concentration of serotonin	The concentration of serotonin by ELISA	FMT capsule/placebo treatment after 4 weeks
Other	The concentration of norepinephrine	The concentration of norepinephrine by ELISA	FMT capsule/placebo treatment after 4 weeks
Other	The concentration of dopamine	The concentration of dopamine by ELISA	FMT capsule/placebo treatment after 4 weeks
Other	The concentration of ?- aminobutyric acid	The concentration of ?- aminobutyric acid by ELISA	FMT capsule/placebo treatment after 4 weeks
Other	The concentration of melatonin	The concentration of melatonin by ELISA	FMT capsule/placebo treatment after 4 weeks
Other	The concentration of interleukin-6	The concentration of interleukin-6 by ELISA	FMT capsule/placebo treatment after 4 weeks
Other	The concentration of interleukin-1 ß	The concentration of interleukin-1 ß by ELISA	FMT capsule/placebo treatment after 4 weeks
Other	The concentration of tumor Necrosis Factor -a	The concentration of tumor Necrosis Factor -a by ELISA	FMT capsule/placebo treatment after 4 weeks
Other	The concentration of interleukin-10	The concentration of interleukin-10 by ELISA	FMT capsule/placebo treatment after 4 weeks
Other	The concentration of follicle-stimulating hormone	The concentration of follicle-stimulating hormone by ELISA	FMT capsule/placebo treatment after 4 weeks
Other	The concentration of estradiol	The concentration of estradiol by ELISA	FMT capsule/placebo treatment after 4 weeks
Primary	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	The metagenomic measure the types of gut microbiota	The metagenomic measure the types of gut microbiota	FMT capsule/placebo treatment after 4 weeks