Probiotics Regulate Intestinal Health and Alleviate Anxiety

January 19, 2026 updated by: Wecare Probiotics Co., Ltd.

Effects of Probiotics on Alleviating Anxiety and Depression and Gut Microbiota

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Luoyang, Henan, China, 462000
        • Henan University of Science and Technolog

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Adults aged 18-65 years.
  2. Individuals experiencing scientific research, employment-related, or occupational stress, including graduate students or community-dwelling adults with job-related pressure.
  3. A Hamilton Depression Rating Scale (HAMD-17) score ≥ 8 and/or a Hamilton 4) Anxiety Rating Scale (HAMA-14) score ≥ 7 at screening.

5)Ability and willingness to voluntarily participate in the study and to provide written informed consent prior to enrollment.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental : probiotics group
5 billion CFU/day BC99 and protein powder; Storage: sealed, protected from light, placed in a cool and dry place.
Dietary supplement: probiotics group
The intervention lasted 8 weeks, with follow-ups at weeks 0 and 12.
Placebo Comparator: Placebo Comparator : placebo group
Dextrin powder, 1 bags per day; Storage: sealed, protected from light, placed in a cool and dry place.
Dietary supplement: Placebo Group
The intervention lasted 8 weeks, with follow-ups at weeks 0 and 12.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the changes in the severity of depressive symptoms.
Time Frame: 8 weeks
The severity of depressive symptoms is assessed by changes in scores on the Hamilton Depression Rating Scale-17 items (HAMD-17) and the Hamilton Anxiety Rating Scale (HAMA-14). The Hamilton Depression Rating Scale (17-item version) is a clinician-administered rating scale consisting of 17 items. The total score ranges from 0 to 52, with higher scores indicating more severe depressive symptoms. The Hamilton Anxiety Rating Scale (14-item version) is a clinician-administered rating scale consisting of 14 items. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2024

Primary Completion (Actual)

June 5, 2024

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

December 25, 2025

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • WK20251224

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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