Anxiety Depression
Conditions
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.
Interventions
DIETARY_SUPPLEMENTprobiotics group
The intervention lasted 8 weeks, with follow-ups at weeks 0 and 12.
DIETARY_SUPPLEMENTPlacebo Group
The intervention lasted 8 weeks, with follow-ups at weeks 0 and 12.
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adults aged 18-65 years. 2. Individuals experiencing scientific research, employment-related, or occupational stress, including graduate students or community-dwelling adults with job-related pressure. 3. 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
1. A confirmed previous diagnosis of other psychiatric disorders, including intellectual disability, bipolar disorder, treatment-resistant depression, or suicidal ideation. 2. Pregnant or breastfeeding women. 3. Individuals with known food or drug allergies, or those with alcohol abuse or psychotropic substance abuse. 4. Use of antibiotics or probiotics known to affect gut microbiota for more than one week within one month prior to enrollment. 5. Participants who withdrew from the study, discontinued intervention, or were unable to complete the study for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the changes in the severity of depressive symptoms. | 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. |
Countries
China
Outcome results
None listed