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【ChiCTR2500109058】A pilot study on the efficacy and safety of the use of a synbiotic formula (SCV09) in people with Mild Cognitive Impairment (MCI)

基本信息
登记号

ChiCTR2500109058

试验状态

尚未开始

药物名称

/

药物类型

/

规范名称

/

首次公示信息日的期

2025-09-11

临床申请受理号

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靶点

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适应症

Mild Cognitive Impairment

试验通俗题目

A pilot study on the efficacy and safety of the use of a synbiotic formula (SCV09) in people with Mild Cognitive Impairment (MCI)

试验专业题目

A pilot study on the efficacy and safety of the use of a synbiotic formula (SCV09) in people with Mild Cognitive Impairment (MCI)

申办单位信息
申请人联系人
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申请人名称
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联系人邮箱
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联系人邮编

联系人通讯地址
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临床试验信息
试验目的

1. To explore the efficacy and safety of a synbiotic formula (SCV09) in improving mood and cognitive symptoms in people with Mild Cognitive Impairment (MCI); 2. To explore the compositional and functional changes in the gut microbiome of people with MCI after treatment with SCV09.

试验分类
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试验类型

单臂

试验分期

其它

随机化

None

盲法

None

试验项目经费来源

None

试验范围

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目标入组人数

30

实际入组人数

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第一例入组时间

2025-09-22

试验终止时间

2026-09-22

是否属于一致性

/

入选标准

1.Chinese individuals aged between 60-85; 2.Mild cognitive impairment as determined by a Clinical Dementia Rating (CDR) = 0.5; 3.Hamilton Depression Rating Scale (HAM-D) >= 8, and that the mood symptoms occurred after MCI onset; 4.Having a family member or caregiver who could supervise the subject in taking the study products, collecting stool samples and attending the follow-up; 5.Able to provide informed consent.;

排除标准

1. Diagnosed with dementia, or already receiving drugs for dementia, such as cholinesterase inhibitors, memantine, and amyloid-targeting monoclonal antibodies; 2. Concomitant Parkinson’s disease and other neurodegenerative conditions affecting activities of daily living 3. Psychotic, suicidal, or treatment-resistant; 4. History of stroke; 5. History of severe organ failure (including decompensated cirrhosis), renal failure on ; dialysis, suffering from human immunodeficiency virus infection; 6. Pre-existing gastrointestinal diseases that significantly confound gut microbiota (eg, inflammatory bowel disease) 7. Confirmed active malignancy; 8. Known operations involving small intestines and large intestines; or history of appendectomy, hysterectomy, and cholecystectomy in the last 6 months; 9. Use of antipsychotics, antidepressants or sedatives, unless on a stable dose in the last 3 months; 10. Inability to receive oral fluids; 11. Use of antibiotics, probiotics or prebiotics in the last 2 weeks; 12. Intolerance to probiotics or lactose leading to a severe allergic reaction.;

研究者信息
研究负责人姓名
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试验机构

The Chinese University of Hong Kong

研究负责人电话
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研究负责人邮箱
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研究负责人邮编

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联系人通讯地址
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