Effectiveness and Safety of Probiotics in Relieving Anxiety and Depression

Wecare Probiotics

Status: Completed

Conditions: Anxiety Depression

Treatments: Dietary Supplement: Probiotic group; Dietary Supplement: Placebo group

Study type: Interventional

Funder types: Industry

Identifiers

NCT06629441

WK2024013

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo group