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Completed

NCT Number: NCT07353320

Probiotics Regulate Intestinal Health and Alleviate Anxiety

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.

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Key information

Conditions

Anxiety Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan University of Science and Technolog

Luoyang, Henan, 462000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

5)Ability and willingness to voluntarily participate in the study and to provide written informed consent prior to enrollment.

Exclusion criteria

  • 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.

Treatment and study plan

probiotics group

Dietary Supplement

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

Placebo Group

Dietary Supplement

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

Primary outcomes

  1. Assess the changes in the severity of depressive symptoms.

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

Effects of Probiotics on Alleviating Anxiety and Depression and Gut Microbiota

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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