Constipation of Depressed Patients
Conditions
Interventions
experimental group:Yakult
Placebo group:Placebo
Sponsors
China Agricultural University.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. People between the age of 18-60 years at the beginning of the study. 2. Normal body mass index: 18.5-29.9. 3. Mild to moderate major depression diagnosed by psychiatrists according to the diagnostic criteria for depressive episodes in DSM-5 (American Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition)). 4. Diagnosis of constipationaccording to the diagnosis of doctors from the Hospital of China Agricultural University. (Diagnosis of constipation is normally performed according to the Rome IV Criteria. Rome IV criteria is as below: (1) Must include two or more of the following: a. Straining during more than one-fourth (25%) of defecations; b. Lumpy or hard stools (Bristol stool form scale 1 or 2) more than one-fourth (25%) of defecations; c. Sensation of incomplete evacuation more than one-fourth (25%) of defecations; d. Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations; e. Manual manoeuvres to facilitate more than one-fourth (25%) of defecations (such as digital evacuation, or support of the pelvic floor); f. Fewer than 3 spontaneous bowel movements per week. (2) Loose stools are rarely present without the use of laxatives. (3) Insufficient criteria for irritable bowel syndrome. Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis) 5. Hamilton Rating Scale for Depression (HRSD) 17 items >= 8 scores. 6. Agreed to drink study product during the study period. 7. Agreed to sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Use of systemic antibiotics or antimycotics medication in the 30 days prior to the study. 2. Use of antidiarrheal or laxative medication in the 30 days prior to the study. 3. Investigator's uncertainty about the willingness or ability of subject to comply with the protocol requirements. 4. Persons with a milk protein allergy, lactose intolerance, or constipation of organic or neurological origin. 5. Pregnant or breastfeeding women. 6. Start using antidepressants within two weeks. 7. Participation in any other studies within two months prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| severity of constipation; | — |
Secondary
| Measure | Time frame |
|---|---|
| depressive symptoms;intestinal microbiota;mmune factors (IL-6, IL-1ß, TNF-a);serum cortisol;serum BDNF; | — |
Countries
China
Contacts
Public ContactRen Fazheng
China Agricultural University
Outcome results
None listed