NCT03377322已完成不适用
A Randomized Double-Blinded Placebo-Controlled Trial of Probiotics for Constipation in Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in frequency of bowel opening per week
研究概览
简要总结
This is a double blinded randomised placebo controlled trial to evaluate the efficacy of probiotics in the treatment of constipation in 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 to 80 years old
- •Provision of written informed consent
- •Diagnosis of PD made by a Neurologist using UK Brain Bank Criteria
- •Fulfils criteria for functional constipation according to the Rome IV Criteria during in the preceding 6 months with frequency of bowel movements less than 3 times per week
排除标准
- •Ingestion of probiotics in the preceding 4 weeks
- •Use of antibiotics in the preceding 4 weeks
- •History of gastrointestinal disorders or surgery
- •Known or suspected allergy to probiotics
- •Comorbidities that prevent reliable completion of study assessments
- •Prior functional neurosurgery for PD or treatment with apomorphine infusion
- •Recent initiation of dopaminergic medications in the preceding 3 months
研究组 & 干预措施
Treatment
Active Comparator
Probiotics capsules
干预措施: Probiotic Capsule (Drug)
Placebo
Placebo Comparator
Placebo capsules containing maltodextrin
干预措施: Placebo Capsule (Drug)
结局指标
主要结局
Change in frequency of bowel opening per week
时间窗: Week 4 post randomisation
Average number of bowel opening per week based on stool diary
次要结局
- Change in patient's quality of life in relation to constipation(Week 4 post randomisation)
- Change in constipation severity score(Week 4 post randomisation)
- Change in stool consistency(Week 4 post randomisation)
研究者
研究点 (1)
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