Effect of Probiotic on Comorbidity of Depression and Constipation

Not Applicable

• Conditions: Comorbidity of Depression and Constipation
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT04570072
• 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%. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-25
• Last Update Submitted: 2020-09-25
• Study First Posted: 2020-09-30
• Last Update Posted: 2020-09-30
• Study Start: 2020-11-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Formula probiotic contains freeze-dried Lactobacillus paracasei, Bifidobacterium animals, Bifidobacterium longum, Bifidobacterium bifidum, and Lactobacillus plantarum, each at a dosage of 3.0 × 10\^10 colony forming unit 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	Change from baseline score to intervention measurements at 4 and 8 weeks	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 cortisol	changes from baseline level to intervention measurements at 4 and 8 weeks	Serum cortisol levels before and after intervention assessed by ELISA.
Serum Il-1β	changes from baseline level to intervention measurements at 4 and 8 weeks	Serum Il-1β levels before and after intervention assessed by ELISA.
Patient Assessment of Constipation Symptom	changes from baseline score to intervention measurements at 4 and 8 weeks	Constipation symptoms as measured with the Patient Assessment of Constipation Symptom. The score ranges from 0 to 48. The higher score means severer constipated symptoms.
Serum TNF-α	changes from baseline level to intervention measurements at 4 and 8 weeks	Serum TNF-α levels before and after intervention assessed by ELISA.
Serum Il-6	changes from baseline level to intervention measurements at 4 and 8 weeks	Serum Il-6 levels before and after intervention assessed by ELISA.
Serum Brain-derived neurotrophic factor	changes from baseline level to intervention measurements at 4 and 8 weeks	Serum Brain-derived neurotrophic factor levels before and after intervention assessed by ELISA.
Serum concentrations of tryptophan metabolites	Changes from baseline level to intervention measurements at 4 and 8 weeks	Serum concentrations of tryptophan metabolites quantified by High-Performance Liquid Chromatography and Mass Spectrometry
Serum concentrations of bile acid	Changes from baseline level to intervention measurements at 4 and 8 weeks	Quantification by High-Performance Liquid Chromatography and Mass Spectrometry
Fecal microbiome	Changes from baseline to intervention measurements at 4 and 8 weeks	Fecal microbiome measured by next generation sequencing
Stool form	Change from baseline score to intervention measurements at 4 and 8 weeks	Stool form measured with the Bristol Stool Form Scale, which classify the form of human faeces into seven types, successively named type 1 to type 7. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea.

Trial Locations

Locations (1)

The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine; 🇨🇳 Nanjing, Jiangsu, China