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OpenTrials
Completed

NCT Number: NCT04567147

Effect of Probiotic on Depression

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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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Chinese Medicine Hospital Pinggu Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: 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 outcomes

  1. Fecal microbiome

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

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

  2. Serum Il-1β

    Time frame: change from baseline to intervention measurements at 8 weeks

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

  3. Serum Il-6

    Time frame: change from baseline to intervention measurements at 8 weeks

    Serum Il-6 levels before and after intervention assessed by ELISA.

  4. Serum TNF-α

    Time frame: change from baseline to intervention measurements at 8 weeks

    Serum TNF-α levels before and after intervention assessed by ELISA.

  5. Serum cortisol

    Time frame: change from baseline to intervention measurements at 8 weeks

    Serum cortisol levels before and after intervention assessed by ELISA.

  6. Serum Brain-derived neurotrophic factor

    Time frame: change from baseline to intervention measurements at 8 weeks

    Serum Brain-derived neurotrophic factor levels before and after intervention assessed by ELISA.

Sponsors and collaborators

Lead sponsor

China Agricultural University

Other

Registry information

Official study title

Effect of Probiotic on Depressive Symptom in Chinese Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 28, 2020
Registry last updated
Sep 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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