Depression
Conditions
Brief summary
Depressive disorder, also known as depression, is a type of mood disorder characterized by persistent low mood. The incidence of depression worldwide is about 6%. Growing evidence suggested that the gut microbiota plays a key role in the development of depression. Probiotics can effectively regulate gut microbiota, and showed potential in alleviating depression. This study investigated the effect of formula probiotic (containing Lactobacillus paracasei, Bifidobacterium animalis, Bifidobacterium longum, Bifidobacterium bifidum and Lactobacillus plantarum) on depression.
Interventions
DIETARY_SUPPLEMENTProbiotic
Patients received the formula probiotic for consecutive 8 weeks ( one sachet per day ).
DIETARY_SUPPLEMENTPlacebo
Patients received the placebo identical to probiotic for consecutive 8 weeks ( one sachet per day ).
Sponsors
China Agricultural University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Normal body mass index ≥ 18.5 until ≤ 29.9 * 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)) * Hamilton Rating Scale for Depression (HAMD-17) score not less than 8 * Agreed to intake study product during the study period * Agreed to sign written informed consent
Exclusion criteria
* Use of systemic antibiotics or antimycotics medication in the 30 days prior to the study * Investigator's uncertainty about the willingness or ability of subject to comply with the protocol requirements * Persons with a milk protein allergy, lactose intolerance * Pregnant or breastfeeding women * Subject had other serious diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale | Changes in the HAMD score at baseline and 8-week intervention | Depressive symptoms as measured with the Hamilton Rating Scale for Depression. The score rangs from 0 to 53. The higher score means severer depressive symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal microbiome | Changes between at baseline and 8-week intervention | changes in the profile of gut microbiota before and after 8-week intervention. |
| Serum Il-1β | change from baseline to intervention measurements at 8 weeks | Serum Il-1β levels before and after intervention assessed by ELISA. |
| Serum Il-6 | change from baseline to intervention measurements at 8 weeks | Serum Il-6 levels before and after intervention assessed by ELISA. |
| Serum TNF-α | change from baseline to intervention measurements at 8 weeks | Serum TNF-α levels before and after intervention assessed by ELISA. |
| Serum cortisol | change from baseline to intervention measurements at 8 weeks | Serum cortisol levels before and after intervention assessed by ELISA. |
| Serum Brain-derived neurotrophic factor | change from baseline to intervention measurements at 8 weeks | Serum Brain-derived neurotrophic factor levels before and after intervention assessed by ELISA. |
Countries
China
Outcome results
None listed