Effect of Probiotic on Depression

China Agricultural University

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04567147

CAUDepression-01

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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89 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

Formula probiotic contains freeze-dried Lactobacillus casei, Bafidobacterium animals, Bifidobacterium longum, Bifidobacterium bidium and Lactobacillus plantarum, each at a dosage of 3.0E+10 CFU per 2g sachet.

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

Placebo made with only the excipients. The placebo sachet was matched to the study probiotic products for taste, color, and size.

Treatment:

Dietary Supplement: Placebo