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Clinical Trials/NCT07353320
NCT07353320
Completed
Not Applicable

Effects of Probiotics on Alleviating Anxiety and Depression and Gut Microbiota

Wecare Probiotics Co., Ltd.0 sites79 target enrollmentStarted: April 10, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
79

Overview

Brief Summary

This study is a randomized, double-blind, placebo-controlled trial aimed primarily at investigating the effects of Weizmannia coagulans BC99 on alleviating anxiety and depression and the gut microbiota.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Adults aged 18-65 years.
  • Individuals experiencing scientific research, employment-related, or occupational stress, including graduate students or community-dwelling adults with job-related pressure.
  • A Hamilton Depression Rating Scale (HAMD-17) score ≥ 8 and/or a Hamilton 4) Anxiety Rating Scale (HAMA-14) score ≥ 7 at screening.
  • Ability and willingness to voluntarily participate in the study and to provide written informed consent prior to enrollment.

Exclusion Criteria

  • A confirmed previous diagnosis of other psychiatric disorders, including intellectual disability, bipolar disorder, treatment-resistant depression, or suicidal ideation.
  • Pregnant or breastfeeding women.
  • Individuals with known food or drug allergies, or those with alcohol abuse or psychotropic substance abuse.
  • Use of antibiotics or probiotics known to affect gut microbiota for more than one week within one month prior to enrollment.
  • Participants who withdrew from the study, discontinued intervention, or were unable to complete the study for any reason.

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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