Probiotics Regulate Intestinal Health and Alleviate Anxiety

NCT07353320 | Completed

• 1 other identifier: WK20251224
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, placebo-controlled trial aimed primarily at investigating the effects of Weizmannia coagulans BC99 on alleviating anxiety and depression and the gut microbiota.

Conditions

Anxiety Depression

Outcome Measures

Primary Outcomes (1)

• Assess the changes in the severity of depressive symptoms.

  The severity of depressive symptoms is assessed by changes in scores on the Hamilton Depression Rating Scale-17 items (HAMD-17) and the Hamilton Anxiety Rating Scale (HAMA-14). The Hamilton Depression Rating Scale (17-item version) is a clinician-administered rating scale consisting of 17 items. The total score ranges from 0 to 52, with higher scores indicating more severe depressive symptoms. The Hamilton Anxiety Rating Scale (14-item version) is a clinician-administered rating scale consisting of 14 items. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms.

  8 weeks

Study Arms (2)

Experimental : probiotics group

EXPERIMENTAL

5 billion CFU/day BC99 and protein powder; Storage: sealed, protected from light, placed in a cool and dry place.

Dietary Supplement: probiotics group

Placebo Comparator : placebo group

PLACEBO COMPARATOR

Dextrin powder, 1 bags per day; Storage: sealed, protected from light, placed in a cool and dry place.

Dietary Supplement: Placebo Group

Interventions

probiotics group DIETARY_SUPPLEMENT

The intervention lasted 8 weeks, with follow-ups at weeks 0 and 12.

Experimental : probiotics group

Placebo Group DIETARY_SUPPLEMENT

The intervention lasted 8 weeks, with follow-ups at weeks 0 and 12.

Placebo Comparator : placebo group

Eligibility Criteria

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

You may qualify if:

• Adults aged 18-65 years.
• Individuals experiencing scientific research, employment-related, or occupational stress, including graduate students or community-dwelling adults with job-related pressure.
• A Hamilton Depression Rating Scale (HAMD-17) score ≥ 8 and/or a Hamilton 4) Anxiety Rating Scale (HAMA-14) score ≥ 7 at screening.
• )Ability and willingness to voluntarily participate in the study and to provide written informed consent prior to enrollment.

You may not qualify if:

• A confirmed previous diagnosis of other psychiatric disorders, including intellectual disability, bipolar disorder, treatment-resistant depression, or suicidal ideation.
• Pregnant or breastfeeding women.
• Individuals with known food or drug allergies, or those with alcohol abuse or psychotropic substance abuse.
• Use of antibiotics or probiotics known to affect gut microbiota for more than one week within one month prior to enrollment.
• Participants who withdrew from the study, discontinued intervention, or were unable to complete the study for any reason.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Henan University of Science and Technolog

Luoyang, Henan, 462000, China

Location

Study Design

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

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 20, 2026
• Study Start: April 10, 2024
• Primary Completion: June 5, 2024
• Study Completion: April 1, 2025
• Last Updated: January 20, 2026

Record last verified: 2025-04

Locations

CN (1)