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CompletedNCT06629441Updated Aug 19, 2025

Effectiveness and Safety of Probiotics in Relieving Anxiety and Depression

An interventional study of Probiotic 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 2025-08-19.

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

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To evaluate the effectiveness and safety of probiotics in relieving anxiety and depression in adults, in comparison with placebo.

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. Voluntary, Written, and Signed Informed Consent: Agreeing to participate in the study.
  2. Ability to Complete the Study According to Protocol: Able to meet the requirements of the study protocol.
  3. Age: 18-65 years old.

  4. Depression and Anxiety Scores:

    • Hamilton Depression Rating Scale (HAMD-17) score of 20 or higher, or
    • Hamilton Anxiety Rating Scale (HAMA) score of 14 or higher.
  5. No History of Certain Conditions: No history of heart, liver, kidney, nervous system, psychiatric disorders, or metabolic abnormalities.

Exclusion criteria

Exclusion Criteria:

  1. Past Diagnosis of Certain Conditions: Individuals with a history of other clearly diagnosed psychiatric disorders, intellectual disabilities, consciousness disorders, complete aphasia, bipolar disorder, treatment-resistant depression, or suicidal thoughts.
  2. Pregnant or Breastfeeding Women: Individuals who are pregnant or breastfeeding.
  3. Use of Certain Medications: Individuals who have used anti-anxiety, anti-depressant medications, or mood stabilizers within the past month.
  4. Allergy History: Individuals with allergic constitutions or a history of drug allergies, or those with severe systemic diseases.
  5. Substance Abuse History: Individuals with a history of alcohol or psychoactive substance abuse within the past 3 months.
  6. Impact of Medications on Gut Microbiota: Individuals who have used medications affecting gut microbiota (including antibiotics, probiotics, mucosal protectors, traditional Chinese medicine, etc.) continuously for more than 1 week in the month prior to screening.
  7. Discontinuation or Addition of Medications: Individuals who have stopped taking the study medication or started taking other medications, making it difficult to assess efficacy or with incomplete data.
  8. Use of Similar Products: Individuals who have taken items similar to the study product in the short term, affecting the evaluation of results.
  9. Inability to Participate: Research participants who cannot participate in the study due to personal reasons.
  10. Other Exclusions: Participants deemed unsuitable for the study by the researchers.
05

Study design

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

Study arms

  • Experimental
    Probiotic group

    10B CFU/Sachet/Day BC99, before meals, Storage: Store in cool and dry place without sun exposure.

    Dietary Supplement: Probiotic group

  • Placebo comparator
    Placebo

    Maltodextrin Sachet/Day, before meals, Storage: Store in cool and dry place without sun exposure.

    Dietary Supplement: Placebo group

Interventions

  • Dietary supplementProbiotic group

    taking 10 billion CFU probiotic one sachet one time, lasting 56 days.

  • Dietary supplementPlacebo group

    taking maltodaxtrin one sachet one time, lasting 56 days.

06

What researchers measure

Primary outcomes

  1. Change in Hamilton Depression Rating Scale (HAMD-17) total score from baseline to Week 8

    Clinician-rated HAMD-17; higher scores indicate more severe depressive symptoms. Negative change denotes improvement.

    Time frame: Baseline and Week 8

07

Study locations

1 site
  • The 1st Affiliated Hospital of He'nan University of Science and Technology
    Luoyang, Henan, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06629441
Lead sponsor
Wecare Probiotics Co., Ltd.
Responsible party
Sponsor
First posted
Oct 8, 2024
Start date
Jun 20, 2024
Primary completion
Dec 15, 2024
Completion
Jan 14, 2025
Last update
Aug 19, 2025

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 Feb 2025. You cannot join it, but the record below documents what was studied.

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