Clinical trial NCT04567147: Effect of Probiotic on Depression
Official title: Effect of Probiotic on Depressive Symptom in Chinese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Lead sponsor: China Agricultural University
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: Changes in the HAMD score at baseline and 8-week intervention
Secondary outcomes:
measure: Fecal microbiome
timeFrame: Changes between at baseline and 8-week intervention
measure: Serum Il-1β
timeFrame: change from baseline to intervention measurements at 8 weeks
measure: Serum Il-6
timeFrame: change from baseline to intervention measurements at 8 weeks
measure: Serum TNF-α
timeFrame: change from baseline to intervention measurements at 8 weeks
measure: Serum cortisol
timeFrame: change from baseline to intervention measurements at 8 weeks
measure: Serum Brain-derived neurotrophic factor
timeFrame: change from baseline to intervention measurements at 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chinese Medicine Hospital Pinggu Hospital
Study officials:
References:
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citation: Akkasheh G, Kashani-Poor Z, Tajabadi-Ebrahimi M, Jafari P, Akbari H, Taghizadeh M, Memarzadeh MR, Asemi Z, Esmaillzadeh A. Clinical and metabolic response to probiotic administration in patients with major depressive disorder: A randomized, double-blind, placebo-controlled trial. Nutrition. 2016 Mar;32(3):315-20. doi: 10.1016/j.nut.2015.09.003. Epub 2015 Sep 28.