Major Depressive Disorder
Conditions
Interventions
Intervention group:Saccharomyces boulardii probiotics
participants in the intervention group consumed one sachet of Saccharomyces boulardii powder every morning at breakfast, with a dosage of 5 x 10^9 colony-forming units (CFU).
Control group:Placebo
participants in the control group received a placebo sachet with an identical appearance, containing only maltodextrin and no Saccharomyces boulardii strain. The placebo was indistinguishable from Sac
Sponsors
Wuhan university
Eligibility
Sex/Gender
All
Age
13 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age between 13 and 18 years old, voluntarily participating and completing the study with informed consent from their guardian. 2. Participants meet the diagnostic criteria for depression as per the Chinese Classification of Mental Disorders, 3rd edition (CCMD-3). 3. Normal language and hearing abilities. 4. Participants do not consume probiotic-rich fermented foods during the study. 5. All participants are on a stable dose of the same antidepressant medication for at least 6 weeks prior to the study, and are required to maintain this regimen throughout the study.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of bipolar disorder. 2. Plans for hospitalization or surgery within 3 months. 3. History of allergic reactions within 3 months prior to the trial. 4. Allergy to any components of the supplement (Saccharomyces boulardii, maltodextrin). 5. Body mass index (BMI) over 30. 6. Use of systemic antibiotics or antifungal agents within 3 months prior to the trial. 7. Intake of other probiotics within 3 months prior to the trial. 8. Vegetarian diet. Additionally, participants who experience serious adverse reactions will be withdrawn from the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression score; | — |
Secondary
| Measure | Time frame |
|---|---|
| anxiety score;Overall clinical status;Salivary cortisol;Gut microbiota;Short-chain fatty acids (SCFAs); | — |
Countries
China
Contacts
Public ContactRui Li
School of Nursing, Wuhan University
Outcome results
None listed