FMT Capsules in Treatment of Patients With Insomnia Clinical Research

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Insomnia
• Intervention / Treatment: Drug: FMT capsule

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanling Wei, MD; Phone Number: 86 15310354666; Email: lingzi016@126.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Third Military Medical University Daping Hospital
      • Contact: Yanling M Wei, MD; Phone Number: +8615310354666; Email: lingzi016@tmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMT capsule treatment group; drugs use generic name: FMT capsule dosage form: capsule dosage, frequency: 16 capsules once a week duration: 4 weeks	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
Placebo Comparator: Placebo treatment group; drugs use generic name: Placebo dosage form:capsule dosage,frequency:16 capsules once a week duration:4 weeks	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The concentration of serotonin	The concentration of serotonin by ELISA	FMT capsule/placebo treatment after 4 weeks
The concentration of norepinephrine	The concentration of norepinephrine by ELISA	FMT capsule/placebo treatment after 4 weeks
The concentration of dopamine	The concentration of dopamine by ELISA	FMT capsule/placebo treatment after 4 weeks
The concentration of ϒ- aminobutyric acid	The concentration of ϒ- aminobutyric acid by ELISA	FMT capsule/placebo treatment after 4 weeks
The concentration of melatonin	The concentration of melatonin by ELISA	FMT capsule/placebo treatment after 4 weeks
The concentration of interleukin-6	The concentration of interleukin-6 by ELISA	FMT capsule/placebo treatment after 4 weeks
The concentration of interleukin-1 β	The concentration of interleukin-1 β by ELISA	FMT capsule/placebo treatment after 4 weeks
The concentration of tumor Necrosis Factor -α	The concentration of tumor Necrosis Factor -α by ELISA	FMT capsule/placebo treatment after 4 weeks
The concentration of interleukin-10	The concentration of interleukin-10 by ELISA	FMT capsule/placebo treatment after 4 weeks
The concentration of follicle-stimulating hormone	The concentration of follicle-stimulating hormone by ELISA	FMT capsule/placebo treatment after 4 weeks
The concentration of estradiol	The concentration of estradiol by ELISA	FMT capsule/placebo treatment after 4 weeks

Collaborators and Investigators

• Sponsor: Third Military Medical University
• Investigators: Study Director: Yanling Wei, Third Military Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 20, 2022
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Insomnia; FMT
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: FMT-202201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No