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FMT Capsules in Treatment of Patients With Insomnia Clinical Research

Primary Purpose

Chronic Insomnia

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

FMT capsule

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring FMT, Insomnia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Third Military Medical University Daping HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FMT capsule treatment group

Placebo treatment group

Arm Description

drugs use generic name: FMT capsule dosage form: capsule dosage, frequency: 16 capsules once a week duration: 4 weeks

drugs use generic name: Placebo dosage form:capsule dosage,frequency:16 capsules once a week duration:4 weeks

Outcomes

Primary Outcome Measures

PSQI scale was used to assess sleep

Pittsburgh sleep quality index scale was used to assess sleep

Secondary Outcome Measures

The metagenomic measure the types of gut microbiota

Full Information

NCT ID

NCT05427331

First Posted

June 1, 2022

Last Updated

June 16, 2022

Sponsor

Third Military Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05427331

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 20, 2022 (Anticipated)

Primary Completion Date

May 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Insomnia

Keywords

FMT, Insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FMT capsule treatment group

Arm Type

Experimental

Arm Description

drugs use generic name: FMT capsule dosage form: capsule dosage, frequency: 16 capsules once a week duration: 4 weeks

Arm Title

Placebo treatment group

Arm Type

Placebo Comparator

Arm Description

drugs use generic name: Placebo dosage form:capsule dosage,frequency:16 capsules once a week duration:4 weeks

Intervention Type

Drug

Intervention Name(s)

FMT capsule

Intervention Description

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

Primary Outcome Measure Information:

Title

PSQI scale was used to assess sleep

Description

Pittsburgh sleep quality index scale was used to assess sleep

Time Frame

FMT capsule/placebo treatment after 4 weeks

Secondary Outcome Measure Information:

Title

The metagenomic measure the types of gut microbiota

Description

The metagenomic measure the types of gut microbiota

Time Frame

FMT capsule/placebo treatment after 4 weeks

Other Pre-specified Outcome Measures:

Title

The concentration of serotonin

Description

The concentration of serotonin by ELISA

Time Frame

FMT capsule/placebo treatment after 4 weeks

Title

The concentration of norepinephrine

Description

The concentration of norepinephrine by ELISA

Time Frame

FMT capsule/placebo treatment after 4 weeks

Title

The concentration of dopamine

Description

The concentration of dopamine by ELISA

Time Frame

FMT capsule/placebo treatment after 4 weeks

Title

The concentration of ϒ- aminobutyric acid

Description

The concentration of ϒ- aminobutyric acid by ELISA

Time Frame

FMT capsule/placebo treatment after 4 weeks

Title

The concentration of melatonin

Description

The concentration of melatonin by ELISA

Time Frame

FMT capsule/placebo treatment after 4 weeks

Title

The concentration of interleukin-6

Description

The concentration of interleukin-6 by ELISA

Time Frame

FMT capsule/placebo treatment after 4 weeks

Title

The concentration of interleukin-1 β

Description

The concentration of interleukin-1 β by ELISA

Time Frame

FMT capsule/placebo treatment after 4 weeks

Title

The concentration of tumor Necrosis Factor -α

Description

The concentration of tumor Necrosis Factor -α by ELISA

Time Frame

FMT capsule/placebo treatment after 4 weeks

Title

The concentration of interleukin-10

Description

The concentration of interleukin-10 by ELISA

Time Frame

FMT capsule/placebo treatment after 4 weeks

Title

The concentration of follicle-stimulating hormone

Description

The concentration of follicle-stimulating hormone by ELISA

Time Frame

FMT capsule/placebo treatment after 4 weeks

Title

The concentration of estradiol

Description

The concentration of estradiol by ELISA

Time Frame

FMT capsule/placebo treatment after 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yanling Wei, MD

Phone

15310354666

Ext

lingzi016@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanling Wei

Organizational Affiliation

Third Military Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Third Military Medical University Daping Hospital

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400042

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanling M Wei, MD

Phone

+8615310354666

lingzi016@tmmu.edu.cn

12. IPD Sharing Statement

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FMT Capsules in Treatment of Patients With Insomnia Clinical Research

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