Insomnia
Conditions
Interventions
Experimental group:Oral enterobacteriaceae capsules
Control group:Oral placebo
Sponsors
Army Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. No gender limit, adults aged 18-70 years; 2. Definite diagnosis of insomnia with a course of more than 3 months (the diagnostic criteria refer to the diagnostic criteria for insomnia in the International Classification of Sleep Disorders, Third Edition (ICSD3), and Pittsburgh Sleep Quality Index score -PSQI > 15); 3. Stable vital signs, clear mind, no communication and cognitive impairment, able to cooperate with the questionnaire survey; 4. Agree to participate in the study and sign the informed consent; 5. Be able to receive return visit, follow-up examination and sample collection on time.
Exclusion criteria
Exclusion criteria: 1. Patients who took probiotics or prebiotics within 3 months before enrollment; 2. Patients who used antibiotics within 3 months before enrollment; 3. Patients with a history of heavy smoking (>=10 cigarettes/day) or dependence on alcohol, coffee and strong tea; 4. Dependent on tube feeding; 5. Have a history of severe allergies; 6. Patients with serious cardiovascular and cerebrovascular diseases, liver and kidney disorders, gastrointestinal diseases and other organic diseases; 7. Patients unable to cooperate with the study; 8. Pregnant or lactating patients; 9. Suffering from depression, anxiety, schizophrenia or other serious mental illness; 10. Suffering from secondary insomnia caused by physical or mental disorders; 11. Other patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut Microbiota;Neurotransmitters;Cytokine;Sex Hormone; | — |
Countries
China
Contacts
Public ContactWei Yanling
Army Medical Center
Outcome results
None listed