NCT05427331

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

June 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

12 months

First QC Date

June 1, 2022

Last Update Submit

June 16, 2022

Conditions

Chronic Insomnia

Keywords

FMTInsomnia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The metagenomic measure the types of gut microbiota

    FMT capsule/placebo treatment after 4 weeks

Other Outcomes (11)

  • The concentration of serotonin

    FMT capsule/placebo treatment after 4 weeks

  • The concentration of norepinephrine

    FMT capsule/placebo treatment after 4 weeks

  • The concentration of dopamine

    FMT capsule/placebo treatment after 4 weeks

  • +8 more other outcomes

Study Arms (2)

FMT capsule treatment group

EXPERIMENTAL

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

Drug: FMT capsule

Placebo treatment group

PLACEBO COMPARATOR

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

Drug: FMT capsule

Interventions

FMT capsuleDRUG

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

FMT capsule treatment groupPlacebo treatment group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Military Medical University Daping Hospital

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Yanling Wei

    Third Military Medical University

    STUDY DIRECTOR

Central Study Contacts

Yanling Wei, MD

CONTACT

15310354666lingzi016@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Gastroenterology, Daping Hospital

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 22, 2022

Study Start

June 20, 2022

Primary Completion

May 31, 2023

Study Completion

December 31, 2023

Last Updated

June 22, 2022

Record last verified: 2022-06

Locations

CN(1)