insomnia
Conditions
Interventions
Group A:Bifidobacterium lactis Bbm-19
Group B:Placebo
Sponsors
Weihai Municipal Hospital, Shandong Province
Eligibility
Sex/Gender
All
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. To meet the diagnostic criteria for insomnia; 2. Meets the Rome IV diagnostic criteria for functional bowel disease; 3. Age 45-70 years old. 4. Agree to participate in this study and sign the informed consent form. The patients were conscious and able to cooperate to complete the examination operation, questionnaire survey, and medical history taking by themselves or with the help of their family members.
Exclusion criteria
Exclusion criteria: 1. Physical or pharmacological treatment for sleep disorders prior to enrollment; 2. Those who have severe cognitive dysfunction to the extent that it affects written and verbal expression; 3. Neurological and psychiatric diseases (Alzheimer's disease, vascular dementia, Parkinson's disease, stroke, and major depression), severe multi-organ diseases (anemia, lung disease, cancer), and other diseases that affect cognition; 4. Patients with chronic digestive diseases (such as peptic ulcer, inflammatory bowel disease, intestinal obstruction, cirrhosis of the liver), tumors, immune disorders, thyroid dysfunction, severe cardiopulmonary disease, renal failure, or other serious physical illnesses; 5. Patients who need to take immunosuppressants for a long time or who have taken antibiotics within 1 month before enrollment and during follow-up; 6. Acute gastrointestinal disease within the last 4 weeks; 7. Patients who are also taking bowel-promoting drugs, such as polyethylene glycol electrolytes, phenolphthalein tablets, senna, etc., during the follow-up period; 8. Those who stopped taking or arbitrarily adjusted the test samples during the follow-up period; 9. Those who are allergic to the test samples or have obvious digestive symptoms that cannot be tolerated; 10. Patients with irregular dietary habits and large changes during the follow-up period; 11. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleepiness Scale (PSQI), Insomnia Severity Index (ISI) Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal Symptom Rating Scale (GSRS), Gastrointestinal Quality of Life Index (GQLI);Montreal Cognitive Assessment Scale (MoCA);Hamilton Anxiety, Depression Inventory - 17 items;Bristol Fecal Characterization Scale; | — |
Countries
China
Contacts
Public ContactZhang Jinbiao
Weihai Municipal Hospital
Outcome results
None listed