Effect of Probiotic on Depression

China Agricultural University89 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Depression

Interventions

ProbioticDIETARY_SUPPLEMENT

Patients received the formula probiotic for consecutive 8 weeks ( one sachet per day ).

PlaceboDIETARY_SUPPLEMENT

Patients received the placebo identical to probiotic for consecutive 8 weeks ( one sachet per day ).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Chinese Medicine Hospital Pinggu Hospital

Beijing, China

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale

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.

Time frame: Changes in the HAMD score at baseline and 8-week intervention

Secondary Outcomes

Fecal microbiome

changes in the profile of gut microbiota before and after 8-week intervention.

Time frame: Changes between at baseline and 8-week intervention

Serum Il-1β

Serum Il-1β levels before and after intervention assessed by ELISA.