Anxiety DepressionNCT07353320
Probiotics Regulate Intestinal Health and Alleviate Anxiety
A study testing probiotics group in people with Anxiety Depression, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial 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. 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?
- probiotics group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2024to 1 Apr 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
- 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.
- 5)Ability and willingness to voluntarily participate in the study and to provide written informed consent prior to enrollment.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anxiety Depression
- Being tested
- probiotics group, Placebo Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotics groupDietary supplement
The intervention lasted 8 weeks, with follow-ups at weeks 0 and 12.
Placebo GroupDietary supplement
The intervention lasted 8 weeks, with follow-ups at weeks 0 and 12.
| Study group | Role | What they receive |
|---|---|---|
| Experimental : probiotics group | Experimental | 5 billion CFU/day BC99 and protein powder; Storage: sealed, protected from light, placed in a cool and dry place. Receives: Dietary Supplement: probiotics group |
| Placebo Comparator : placebo group | Placebo comparator | Dextrin powder, 1 bags per day; Storage: sealed, protected from light, placed in a cool and dry place. Receives: Dietary Supplement: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start10 Apr 2024
- Primary completion5 Jun 2024
- Study completion1 Apr 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
- 79 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
- NCT07353320
- Sponsor's protocol ID
- WK20251224
- Status last verified
- Apr 2025
- First submitted
- 25 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics on Alleviating Anxiety and Depression and Gut Microbiota
- ClinicalTrials.gov ID
- NCT07353320
- Acronym / sponsor ID
- WK20251224
- Conditions
- Anxiety Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 20 Jan 2026 (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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : probiotics group | Experimental | Dietary Supplement: probiotics group5 billion CFU/day BC99 and protein powder; Storage: sealed, protected from light, placed in a cool and dry place. |
| Placebo Comparator : placebo group | Placebo comparator | Dietary Supplement: Placebo GroupDextrin powder, 1 bags per day; Storage: sealed, protected from light, placed in a cool and dry place. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- 5)Ability and willingness to voluntarily participate in the study and to provide written informed consent prior to enrollment.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| probiotics groupThe intervention lasted 8 weeks, with follow-ups at weeks 0 and 12. | Dietary supplement | Experimental : probiotics group |
| Placebo GroupThe intervention lasted 8 weeks, with follow-ups at weeks 0 and 12. | Dietary supplement | Placebo Comparator : placebo group |
Primary outcome
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.
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 20 Jan 2026.
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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 probiotics 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 4 inclusion and 5 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 20 Jan 2026. 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?
Assess the changes in the severity of depressive symptoms. (time frame: 8 weeks). 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 20 Jan 2026.