Effectiveness and Safety of Probiotics in Relieving Anxiety and Depression

NCT06629441 | Completed

• 1 other identifier: WK2024013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety Depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Probiotic group

EXPERIMENTAL

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

Dietary Supplement: Probiotic group

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo group

Interventions

Probiotic group DIETARY_SUPPLEMENT

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

Probiotic group

Placebo group DIETARY_SUPPLEMENT

taking maltodaxtrin one sachet one time, lasting 56 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary, Written, and Signed Informed Consent: Agreeing to participate in the study.
• Ability to Complete the Study According to Protocol: Able to meet the requirements of the study protocol.
• Age: 18-65 years old.
• 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.
• No History of Certain Conditions: No history of heart, liver, kidney, nervous system, psychiatric disorders, or metabolic abnormalities.

You may not qualify if:

• 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.
• Pregnant or Breastfeeding Women: Individuals who are pregnant or breastfeeding.
• Use of Certain Medications: Individuals who have used anti-anxiety, anti-depressant medications, or mood stabilizers within the past month.
• Allergy History: Individuals with allergic constitutions or a history of drug allergies, or those with severe systemic diseases.
• Substance Abuse History: Individuals with a history of alcohol or psychoactive substance abuse within the past 3 months.
• 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.
• 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.
• Use of Similar Products: Individuals who have taken items similar to the study product in the short term, affecting the evaluation of results.
• Inability to Participate: Research participants who cannot participate in the study due to personal reasons.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

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

Luoyang, Henan, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: October 8, 2024
• Study Start: June 20, 2024
• Primary Completion: December 15, 2024
• Study Completion: January 14, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)