insomnia
Conditions
Interventions
Ia-1:Probiotic
Ia-2:Placebo
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Case group inclusion criteria: (1) Patients with primary insomnia disorder who met the ICSD-3 diagnostic criteria; (2) Aged 18-45 years, with approximately the same number of men and women; (3) Han Chinese; (4) Voluntary participation in the study and signed informed consent; (5) The diet is basically the same and stable; (6) Stable sleep rhythm every night for 2 weeks prior to enrolment. 2. Inclusion criteria for the control group: (1) Physically healthy; (2) Aged 18-45 years, with about the same number of men and women; (3) Han Chinese; (4) Voluntary participation in the study and signed informed consent; (5) Basic and stable dietary structure; (6) Regular work and rest, good sleep and hygiene habits.
Exclusion criteria
Exclusion criteria: 1. Current co-morbidity with other psychiatric and behavioural disorders or neurological disorders with cognitive dysfunction; 2. Undergoing or receiving any psychological or psychotropic medication within 3 weeks prior to enrollment; 3. Concomitant somatic disorders of the heart, liver, kidney, brain or gastrointestinal tract or with chronic pain; 4. Are using, or have used within 3 weeks prior to enrolment, antibiotics, anti-inflammatory drugs, probiotics, prebiotics, synbiotics, co-biotics or acid suppressants; 5. Women who are menstruating, planning a pregnancy, or in pregnancy or breastfeeding; 6. Malnutrition or obesity (BMI = 30); 7. consuming tobacco, alcohol, caffeine or other stimulants at bedtime or within 3 weeks prior to enrolment; 8. Consistent smoking >= 1 cigarette/day or consistent alcohol consumption >= 1 drink/week in the last 6 months; 9. Known active bacterial, fungal or viral infection; 10. Being or working on jet lag or shifts or experiencing other psychological stress and stressful events within 3 weeks prior to entry; 11. Are participating in sleep deprivation or related research studies or within 3 weeks prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal flora;Inflammatory factor;Cognitive function; | — |
Countries
China
Contacts
Public ContactYumei Wang
The First Hospital of Hebei Medical University
Outcome results
None listed