Sleep Disorder
Conditions
Interventions
Bifidobacterium breve CCFM1025 group:Daily oral intake of one packet of probiotics (10^9 CFU)
Sponsors
Yixing People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. There are no restrictions on gender and race; 2. Aged 18-65 years; 3. Participants met the International Classification of Sleep Disorders edition 3,(ICSD-3) criteria for the diagnosis of insomnia; 4. Pittsburgh sleep quality index (PSQI) >= 7; 5. Good compliance, able to abide by the requirements of clinical trials; 6. The subject or guardian has signed the informed consent; 7. The subjects fill in the written informed consent form, basic information questionnaire, dietary structure and living condition questionnaire, and promise to cooperate with the research throughout the trial period.
Exclusion criteria
Exclusion criteria: 1. History of ingestion of other probiotics and related products within 4 weeks; 2. History of antibiotic intake within 8 weeks; 3. Allergic to the ingredients of the probiotic product; 4. Those who cannot comply with observation due to working the night shift, irregular lifestyles, or alcoholism; 5. Pregnant or breastfeeding women; 6. People during the preparation for pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI);Self-Rating Scale of Sleep (SRSS);Athens Insomnia Scale (AIS);Montreal Cognitive Assessment (MoCA); | — |
Secondary
| Measure | Time frame |
|---|---|
| fecal microbial analysis;SCFAs in feces;Serological indicators;Indicators of saliva;plasma biochemical index; | — |
Countries
China
Contacts
Public ContactJunjie Lu
Yixing People’s Hospital
Outcome results
None listed