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【ChiCTR2200060234】Dietary interventions on constipation and gut outcomes for people with Parkinson’s disease

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基本信息

登记号

ChiCTR2200060234

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

2022-05-23

临床申请受理号

靶点

适应症

Parkinson's disease

试验通俗题目

Dietary interventions on constipation and gut outcomes for people with Parkinson’s disease

试验专业题目

Healing the gut: A randomized controlled trial on the effects and acceptability of Mediterranean diet (MedDiet) on constipation and gut microbiome in people with Parkinson’s disease

申办单位信息

申请人联系人

申请人名称

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临床试验信息

试验目的

To investigate the effects and acceptability of Mediterranean diet versus high-fibre diet on constipation and gut outcomes in Chinese PD patients over the 8-week study period.

试验分类

试验类型

随机平行对照

试验分期

其它

随机化

Participants will be randomly assigned to experimental (MedDiet) or active control (high fibre diet) groups at a 1:1 ratio through a computer-based permuted block randomization, with random block sizes of 4-8. They will be informed of their assigned group by a person not involved in the assessments. The ran

盲法

All outcome assessors will be blinded to subject allocation.

试验项目经费来源

N/A

试验范围

目标入组人数

实际入组人数

第一例入组时间

2022-05-10

试验终止时间

2026-12-31

是否属于一致性

入选标准

(i) A diagnosis of idiopathic mild-to-moderate PD, as indicated by the Hoehn & Yahr Scale37 Stage I-III (presenting with mild-to-moderate unilateral/bilateral symptoms, some postural instability, physically independent); (ii) be aged ≥18 years; (iii) meet Rome III criteria for functional constipation38 (See Table 1 for the detailed diagnostic criteria); and (iv) be able to give written consent.；

排除标准

(i) Those currently on specific diet prescription/ use of probiotics; (ii) use of antibiotics within 6 weeks before the start of the study; (iii) any inflammatory bowel disease/previous GI tract surgery; (iv) significant cognitive impairment indicated by an Abbreviated Mental Test score ≤6 (sensitivity: 96%; specificity: 94%)39; (v) history of laxative abuse; (vi) other contraindication that may limit full participation (e.g., severe dysphagia); and/or (vii) allergic to one or more of the following: nuts, fish or olive oil.；

研究者信息

研究负责人姓名

试验机构

N/A

研究负责人电话

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