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Effect of Probiotic on Comorbidity of Depression and Constipation

NCT04570072 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-09-30

No results posted yet for this study

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.

Conditions

  • Comorbidity of Depression and Constipation

Interventions

DIETARY_SUPPLEMENT

Probiotic

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine

    collaborator UNKNOWN

  • China Agricultural University

    lead OTHER

Principal Investigators

  • Fazhen Ren, PhD · China Agricultural University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2021-06-30
Completion
2021-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04570072 on ClinicalTrials.gov