Evaluation of the Effect of Probiotic Supplementation on Cognitive, Emotional and Related Status on Alzheimer's Dementia Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Mini-Mental State Examination (MMSE) for efficacy
研究概览
简要总结
The present studies demonstrated that pro-inflammation, systemic oxidative stress and dysfunction in the brain-gut microbiota axis were involved in Alzheimer's disease (AD) pathogenesis. These results implied the decreased regulation of inflammation-associated risk and microbiota in AD patients could provide the novel strategies for combating the disease. This study was designed to assess the addition of Wismemo in treatment of cholinesterase inhibitors (such as donepezil, rivastigmine, galantamine) in the AD patients.
详细描述
Previously studies have shown some probiotics could improve stress-related diseases such as anxiety, autism, depression and schizophrenia might be through regulating brain-gut microbiota axis, pro-inflammation and oxidative stress. Although recent clinical study indicated that mix-probiotics (containing Lactobacillus acidophilus, Lactobacillus casei, Bifidobacteria bifidum and Lactobacillus fermentum) consumption could improve the cognitive function of dementia patients.
In this clinical study, whether Genmont specific strain probiotics could improve the clinical syndromes and delay worsens in Alzheimer's dementia patients with regular treatment were clarified. A Randomized, double-blind, placebo-controlled clinical trial would be carried out. AD's patients with regular treatment are additive consumption multi-strain probiotic supplement (Wismemo). Half of participants will receive Wismeno and regular treatment in combination, while the other half will receive placebo and regular treatment in combination. To evaluate of the effect of probiotic supplementation on cognitive, emotional and related status on Alzheimer's dementia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Alzheimer's Dementia. (According to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association diagnostic criteria (NINCDS-ADRDA) and new criteria and guidelines to diagnose Alzheimer's disease were published in 2011 by the National Institute on Aging and Alzheimer's Association)
- •Subjects with administrating cholinesterase inhibitors, such as donepezil, rivastigmine, galantamine.
- •Subjects in age of 55-95 years old.
排除标准
- •Subjects are mixed dementia and vascular dementia.
- •Administration of probiotic dietary supplement 2 weeks before inclusion expect for yakult or yogurt.
- •Participation in other clinical trials.
- •Subjects with thyroid dysfunction.
- •Subjects are receiving cancer drugs.
- •Subjects are receiving immunosuppressant drugs.
结局指标
主要结局
Mini-Mental State Examination (MMSE) for efficacy
时间窗: 0, 3, 6 months
Change in cognitive status was evaluated using the Mini-Mental State Examination (MMSE). MMSE will be assessed at baseline and after intervention. The maximum score is 30. If the scores are less than 24, it would be assessed to the mild dementia. If the scores are less than 16, it would be assessed to the severe dementia.
次要结局
- Brief Symptom Rating Scale for quality of life(0, 3, 6 months)
- Neuropsychiatric Inventory (NPI) for efficacy and quality of life(0, 3, 6 months)
- Change from baseline in levels of blood sugar (HbA1c)(0 and 6 months)
- Gut microbiota for efficacy(0 and 6 months)
- Change from baseline in levels of inflammatory markers (IL-10,IL-6, IL-1 beta, TNF-alpha and TGF-beta)(0 and 6 months)
- Change from baseline in levels of inflammatory markers (hs-CRP)(0 and 6 months)
- Zarit's Caregiver Burden Scale for quality of life(0, 3, 6 months)
- Change from baseline in levels of insulin resistance profile (FPG, insulin and HOMA-IR)(0 and 6 months)
- Mini-Nutritional Assessment (MNA) for feasibility and efficacy(0, 3, 6 months)
- Fatigue scale for quality of life(0, 3, 6 months)
- Change from baseline in levels of peroxidation and antioxidant profiles (MDA and TAC)(0 and 6 months)
- Defecation frequency and type for feasibility and efficacy(0, 3, 6 months)