depression
Conditions
Interventions
control group:placebo
Treatment group:Microbial live bacteria
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years old; BMI 18.5-29.9 kg/m2; 2. A psychiatrist diagnoses recurrent mild to moderate major depression after a first episode or recovery according to the diagnostic criteria for depressive episode of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 3. Hamilton Depression Scale (HAMD-17) score not less than 8 points; 4. Substance T in feces and serum was lower than the standard value; 5. Have not consumed any probiotic-related food or medicine in the past 2 weeks; 6. No alcohol, no antibiotics, no hormone products, no amiodarone, dopamine, bromocryptotine, phenytoin sodium, lithium and other drugs in the past 3 months; 7. Consent to ingestion of the study product during the study period; 8. Voluntarily participate in and cooperate with the research and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Use of systemic antibiotics or antifungal drugs within 30 days prior to the study; 2. Patients enrolled in clinical trials of other drugs and receiving clinical trials of drugs within 2 months prior to the study; 3. Use of antidepressants within two weeks of the study; 4. Uncertainty of the investigator's willingness or ability to comply with protocol requirements; 5. milk protein allergy, lactose intolerance; 6. Pregnant or lactating women; 7. The subjects had other serious diseases: (1) Myocardial infarction; (2) Cerebral infarction; (3) Cardiac surgery or revascularization (coronary artery bypass bypass/percutaneous coronary angioplasty); (4) Unstable angina pectoris; (5) Congestive heart failure (New York Cardiac Society Grade III or IV); (6) Transient ischemic attack or significant cerebrovascular disease; (7) Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation or acquired immunodeficiency syndrome (AIDS); (8) Personal history of malignant tumor; (9) Contraindications of MRI; (10) Suffering from mental illness such as schizophrenia; (11) People with major depression who have attempted suicide or are suicidal; (12) Mental illness in the immediate family; (13) Patients with depression caused by definite external inducements and persistent external inducements that cannot be removed; 8. Patients unable to complete the entire intervention and follow-up due to various other factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale, HAMD-17;Beck Depression Index;Hamilton Anxiety Scale, HAMA-14;Montreal Cognitive Assessment Scale, MOCA; | — |
Secondary
| Measure | Time frame |
|---|---|
| The level of substance T in the serum;The level of substance T in the fecal;Microbial composition of fecal; | — |
Countries
China
Contacts
Public ContactTian Yanghua
The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed