Effectiveness and Safety of Probiotics in Relieving Anxiety and Depression

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Depression
• Intervention / Treatment: Dietary supplement: Probiotic group; Dietary supplement: Placebo group

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic group; 10B CFU/Sachet/Day BC99, before meals, Storage: Store in cool and dry place without sun exposure.	Dietary supplement: Probiotic group; taking 10 billion CFU probiotic one sachet one time, lasting 56 days.
Placebo Comparator: Placebo; Maltodextrin Sachet/Day, before meals, Storage: Store in cool and dry place without sun exposure.	Dietary supplement: Placebo group; taking maltodaxtrin one sachet one time, lasting 56 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 8

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): January 14, 2025

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Anxiety Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: WK2024013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No