Anxiety DepressionNCT06629441
Effectiveness and Safety of Probiotics in Relieving Anxiety and Depression
A study testing Probiotic group in people with Anxiety Depression, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
To evaluate the effectiveness and safety of probiotics in relieving anxiety and depression in adults, in comparison with placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- Probiotic group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 14 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary, Written, and Signed Informed Consent: Agreeing to participate in the study.
- Ability to Complete the Study According to Protocol: Able to meet the requirements of the study protocol.
- Age: 18-65 years old.
- 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.
- No History of Certain Conditions: No history of heart, liver, kidney, nervous system, psychiatric disorders, or metabolic abnormalities.
Who cannot join
- 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.
- Pregnant or Breastfeeding Women: Individuals who are pregnant or breastfeeding.
- Use of Certain Medications: Individuals who have used anti-anxiety, anti-depressant medications, or mood stabilizers within the past month.
- Allergy History: Individuals with allergic constitutions or a history of drug allergies, or those with severe systemic diseases.
- Substance Abuse History: Individuals with a history of alcohol or psychoactive substance abuse within the past 3 months.
- 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.
Show all 10Show fewer
- 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.
- Use of Similar Products: Individuals who have taken items similar to the study product in the short term, affecting the evaluation of results.
- Inability to Participate: Research participants who cannot participate in the study due to personal reasons.
- Other Exclusions: Participants deemed unsuitable for the study by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
The 1st Affiliated Hospital of He'nan University of Science and Technology
Luoyang, Henan
About this study
Official title: Effectiveness and Safety of Probiotics, BC99 in Relieving Anxiety and Depression in Adults
To evaluate the effectiveness and safety of probiotics in relieving anxiety and depression in adults, in comparison with placebo.
- Conditions
- Anxiety Depression
- Being tested
- Probiotic group, Placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic groupDietary supplement
taking 10 billion CFU probiotic one sachet one time, lasting 56 days.
Placebo groupDietary supplement
taking maltodaxtrin one sachet one time, lasting 56 days.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | 10B CFU/Sachet/Day BC99, before meals, Storage: Store in cool and dry place without sun exposure. Receives: Dietary Supplement: Probiotic group |
| Placebo | Placebo comparator | Maltodextrin Sachet/Day, before meals, Storage: Store in cool and dry place without sun exposure. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start20 Jun 2024
- Primary completion15 Dec 2024
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629441
- Sponsor's protocol ID
- WK2024013
- Status last verified
- Feb 2025
- First submitted
- 18 Sep 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Probiotics, BC99 in Relieving Anxiety and Depression in Adults
- ClinicalTrials.gov ID
- NCT06629441
- Acronym / sponsor ID
- WK2024013
- Conditions
- Anxiety Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness and safety of probiotics in relieving anxiety and depression in adults, in comparison with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic group10B CFU/Sachet/Day BC99, before meals, Storage: Store in cool and dry place without sun exposure. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo groupMaltodextrin Sachet/Day, before meals, Storage: Store in cool and dry place without sun exposure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntary, Written, and Signed Informed Consent: Agreeing to participate in the study.
- Ability to Complete the Study According to Protocol: Able to meet the requirements of the study protocol.
- Age: 18-65 years old.
- Depression and Anxiety Scores:
- No History of Certain Conditions: No history of heart, liver, kidney, nervous system, psychiatric disorders, or metabolic abnormalities.
Key exclusion criteria (10 listed)
- 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.
- Pregnant or Breastfeeding Women: Individuals who are pregnant or breastfeeding.
- Use of Certain Medications: Individuals who have used anti-anxiety, anti-depressant medications, or mood stabilizers within the past month.
- Allergy History: Individuals with allergic constitutions or a history of drug allergies, or those with severe systemic diseases.
- Substance Abuse History: Individuals with a history of alcohol or psychoactive substance abuse within the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic grouptaking 10 billion CFU probiotic one sachet one time, lasting 56 days. | Dietary supplement | Probiotic group |
| Placebo grouptaking maltodaxtrin one sachet one time, lasting 56 days. | Dietary supplement | Placebo |
Primary outcome
Change in Hamilton Depression Rating Scale (HAMD-17) total score from baseline to Week 8
Time frame: Baseline and Week 8
Clinician-rated HAMD-17; higher scores indicate more severe depressive symptoms. Negative change denotes improvement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic group in people with Anxiety Depression, run by Wecare Probiotics Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale (HAMD-17) total score from baseline to Week 8 (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.