CClinicalTrials.gg
CompletedNCT07353320Updated Jan 20, 2026

Probiotics Regulate Intestinal Health and Alleviate Anxiety

An interventional study of probiotics group and Placebo Group in Anxiety Depression, sponsored by Wecare Probiotics Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Apr 2024, registered Dec 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anxiety Depression
03

In context

Lead sponsor

Wecare Probiotics Co., Ltd. is the lead sponsor of 65 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
79 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementprobiotics group

    The intervention lasted 8 weeks, with follow-ups at weeks 0 and 12.

  • Dietary supplementPlacebo Group

    The intervention lasted 8 weeks, with follow-ups at weeks 0 and 12.

06

What researchers measure

Primary outcomes

  1. Assess the changes in the severity of depressive symptoms.

    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.

    Time frame: 8 weeks

07

Study locations

1 site
  • Henan University of Science and Technolog
    Luoyang, Henan 462000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07353320
Lead sponsor
Wecare Probiotics Co., Ltd.
Responsible party
Sponsor
First posted
Jan 20, 2026
Start date
Apr 10, 2024
Primary completion
Jun 5, 2024
Completion
Apr 1, 2025
Last update
Jan 20, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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