Clinical Study Evaluating the Efficacy and Safety of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The change in MDS-Unified Parkinson's Disease Rating Scale.
研究概览
简要总结
This study aims to investigate the possible efficacy and safety of synbiotic preparation of Lactobacillus acidophilus probiotic with prebiotic fibers as an adjuvant therapy in the treatment of Parkinson's disease
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
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 45 and 65 years old
- •Both sexes
- •Patients with Parkinson's disease on dopamine replacement therapy
- •Modified Hoehn and Yahr stage, MHY 1-4
排除标准
- •Patients who are currently using or used antibiotics therapy in the preceding month
- •Patients who are currently using or used other probiotic products in the preceding two weeks
- •Patients scheduled to undergo GIT surgery or those underwent GIT surgery
- •Patients with Known allergy to probiotics
- •Patients receiving artificial enteral or intravenous nutrition
- •Patients with depression and/or psychosis
- •Patients taking antioxidant and/or anti-inflammatory medications
- •Patients with Hyperthyroidism
- •Patients with inflammatory condition and/or condition involving oxidative stress
- •Modified Hoehn & Yahr stage MHY 5
研究组 & 干预措施
Synbiotic group
this group will involve 33 patients who will receive Synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers 2 sachets daily together with their standard dopamine replacement therapy for 3 months
干预措施: Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers (Drug)
结局指标
主要结局
The change in MDS-Unified Parkinson's Disease Rating Scale.
时间窗: 3 months
Patients will undergo clinical assessment according to MDS-Unified Parkinson's Disease Rating Scale at baseline and after 3 months
次要结局
- The change in the serum level of Tumor necrosis factor α (TNF α )(3 months)
- The change in the serum level of Brain derived neurotrophic factor ( BDNF)(3 months)
- The change in the serum level of Malondialdehyde (MDA)(3 months)
- The change in the serum level of α-Synuclein(3 months)
研究者
Mohamed Ehab Sayed Ramadan
Demonstrator at clinical pharmacy department, faculty of pharmacy
Tanta University