Effect of Probiotic on Depression

Phase 1

Completed

• Conditions: Depression
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT04567147
• Lead Sponsor: China Agricultural University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-20
• Primary Completion: 2019-06-22
• Status Verified: 2020-09
• Study Completion: 2020-09-12
• Study First Submitted: 2020-09-20
• Study First Submitted QC: 2020-09-25
• Last Update Submitted: 2020-09-25
• Study First Posted: 2020-09-28
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Serum TNF-α	change from baseline to intervention measurements at 8 weeks	Serum TNF-α levels before and after intervention assessed by ELISA.
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 cortisol	change from baseline to intervention measurements at 8 weeks	Serum cortisol 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 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.

Trial Locations

Locations (1)

Beijing Chinese Medicine Hospital Pinggu Hospital; 🇨🇳 Beijing, China