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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)

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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

靶点

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

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

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

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

目标入组人数

实际入组人数

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

试验机构

The Chinese University of Hong Kong

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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