NCT06629441已完成不适用
Effectiveness and Safety of Probiotics, BC99 in Relieving Anxiety and Depression in Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale (HAMD-17) total score from baseline to Week 8
研究概览
简要总结
To evaluate the effectiveness and safety of probiotics in relieving anxiety and depression in adults, in comparison with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Hamilton Depression Rating Scale (HAMD-17) total score from baseline to Week 8
时间窗: Baseline and Week 8
Clinician-rated HAMD-17; higher scores indicate more severe depressive symptoms. Negative change denotes improvement.
次要结局
未报告次要终点
研究者
研究点 (1)
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