Effect of Probiotic on Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2020-09-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Probiotic

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No