Status:
UNKNOWN
FMT Capsules in Treatment of Patients With Insomnia Clinical Research
Lead Sponsor:
Third Military Medical University
Conditions:
Chronic Insomnia
Eligibility:
All Genders
18-70 years
Phase:
NA
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 fa...
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 metabol...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05427331
Start Date
June 20 2022
End Date
December 31 2023
Last Update
June 22 2022
Active Locations (1)
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1
Third Military Medical University Daping Hospital
Chongqing, Chongqing Municipality, China, 400042