洞察市场格局
解锁药品研发情报

免费客服电话

18983288589

试用企业版

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

查看原文

立即下载

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

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

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

研究负责人邮箱

研究负责人邮编

联系人通讯地址

<END>