Effectiveness and Safety of Probiotics in Relieving Anxiety and Depression

NCT ID: NCT06629441

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2025-01-14

Brief Summary

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

Conditions

Anxiety Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic group

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

Group Type: EXPERIMENTAL

Probiotic group

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: DIETARY_SUPPLEMENT

taking maltodaxtrin one sachet one time, lasting 56 days.

Interventions

Probiotic group

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo group

taking maltodaxtrin one sachet one time, lasting 56 days.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The 1st Affiliated Hospital of He'nan University of Science and Technology

Luoyang, Henan, China

Countries

China

Other Identifiers

WK2024013

Identifier Type: -

Identifier Source: org_study_id