Effectiveness and Safety of Probiotics in Relieving Anxiety and Depression

Not Applicable

Active, not recruiting

• Conditions: Anxiety Depression
• Interventions: Dietary Supplement: Probiotic group; Dietary Supplement: Placebo group

• Registration Number: NCT06629441
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-20
• Status Verified: 2024-07
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Study First Posted: 2024-10-07
• Last Update Posted: 2024-10-07
• Primary Completion: 2024-12-15
• Study Completion: 2025-04-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	Probiotic group	10B CFU/Sachet/Day BC99, before meals, Storage: Store in cool and dry place without sun exposure.
Placebo	Placebo group	Maltodextrin Sachet/Day, before meals, Storage: Store in cool and dry place without sun exposure.

Primary Outcome Measures

Name	Time	Method
Changes in Anxiety Symptoms	56 day	Using the Hamilton Depression Rating Scale (HAMD) questionnaire

Trial Locations

Locations (1)

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