Effectiveness and Safety of Probiotics in Relieving Anxie... | NCT06629441

NCT06629441

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Probiotic group	Dietary Supplement	taking 10 billion CFU probiotic one sachet one time, lasting 56 days.	Probiotic group

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Other Exclusions: Participants deemed unsuitable for the study by the researchers.