Clinical trial NCT04570072: Effect of Probiotic on Comorbidity of Depression and Constipation
Official title: Effect of Probiotic on Chinese Patients With Depression and Constipated Comorbidity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Comorbidity of Depression and Constipation
Lead sponsor: China Agricultural University
Sponsor class: OTHER
Collaborators: name: The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine
First posted: 2020-09-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_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%. The high comorbidity rate between depression and constipation indicated the role of the gut-brain axis in depression. Growing evidence suggested that the gut microbiota plays a key role in the development of depression. Probiotics can effectively improve constipation and regulate gut microbiota, and showed potential in alleviating depression. This study investigated the effect of formula probiotic (containing Lactobacillus paracasei, Bifidobacterium animals, Bifidobacterium longum, Bifidobacterium bifidum, and Lactobacillus plantarum) on the comorbidity of depression and constipation.


Eligibility criteria: Inclusion Criteria:

* Normal body mass index ≥ 18.5 until ≤ 29.9
* Hamilton Rating Scale for Depression (HAMD-17) score not less than 8
* Meet the ROME III criteria for functional constipation
* 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: Change from baseline score to intervention measurements at 4 and 8 weeks
Secondary outcomes:
measure: Patient Assessment of Constipation Symptom
timeFrame: changes from baseline score to intervention measurements at 4 and 8 weeks
measure: Serum Il-1β
timeFrame: changes from baseline level to intervention measurements at 4 and 8 weeks
measure: Serum Il-6
timeFrame: changes from baseline level to intervention measurements at 4 and 8 weeks
measure: Serum TNF-α
timeFrame: changes from baseline level to intervention measurements at 4 and 8 weeks
measure: Serum cortisol
timeFrame: changes from baseline level to intervention measurements at 4 and 8 weeks
measure: Serum Brain-derived neurotrophic factor
timeFrame: changes from baseline level to intervention measurements at 4 and 8 weeks
measure: Serum concentrations of tryptophan metabolites
timeFrame: Changes from baseline level to intervention measurements at 4 and 8 weeks
measure: Serum concentrations of bile acid
timeFrame: Changes from baseline level to intervention measurements at 4 and 8 weeks
measure: Fecal microbiome
timeFrame: Changes from baseline to intervention measurements at 4 and 8 weeks
measure: Stool form
timeFrame: Change from baseline score to intervention measurements at 4 and 8 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine
state: Jiangsu
Study officials:
affiliation: China Agricultural University
name: Fazhen Ren, PhD
role: PRINCIPAL_INVESTIGATOR
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