绿色香蕉混合饮食治疗持续性腹泻的疗效：一项开放标签随机对照试验方案
Efficacy of a Green Banana-Mixed Diet in the Management of Persistent Diarrhea: Protocol for an Open-Labeled, Randomized Controlled Trial.
作者信息
Sarmin Monira, Hossain Md Iqbal, Islam Shoeb Bin, Alam Nur Haque, Sarker Shafiqul Alam, Islam M Munirul, Chisti Mohammod Jobayer, Islam S M Rafiqul, Mahfuz Mustafa, Ahmed Tahmeed
机构信息
Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka Hospital, Dhaka, Bangladesh.
出版信息
JMIR Res Protoc. 2020 Mar 6;9(3):e15759. doi: 10.2196/15759.
BACKGROUND
Diarrhea is the second-leading cause of death in children under 5 years of age. In low- and middle-income countries, 3%-20% of acute diarrheal episodes become persistent diarrhea (PD) (ie, duration ≥14 days), which results in 36%-56% of all diarrheal deaths. In Bangladesh, PD causes >25% of diarrhea-related deaths. Commensal gut microbiota dysbiosis is increasingly recognized in the pathogenesis of PD. Hospital-based management of PD requires a hospital stay, which increases the risk of infection and hospital costs. The higher cost of treatment and high case-fatality rates reiterate PD as an important public health problem. At the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), for the last two decades, a consensus-based guideline has been followed for PD. Observation has revealed that green banana helps in the resolution of diarrhea. However, no larger prospective study has been conducted to evaluate the efficacy of green banana in the management of PD among children older than 6 months of age.
OBJECTIVE
Our objective is to assess the efficacy of full-strength rice suji (semolina) with and without green banana compared to three-quarter-strength rice suji in the management of PD in children aged 6-36 months at the Dhaka Hospital of the icddr,b.
METHODS
This open-labeled, randomized controlled study aims to enroll a total of 145 children with PD who have not been improving on a diet of milk suji. Children will be randomized into three different diet-specific groups: full-strength rice suji containing green banana, full-strength rice suji alone, and three-quarter-strength rice suji. The primary outcome is the percentage of children who recovered from diarrhea by day 5.
RESULTS
Recruitment and data collection began in December 2017 and were completed in November 2019. Results are expected by April 2020.
CONCLUSIONS
This study is expected to provide insights into the incorporation of green banana into the dietary management of PD. This would be the first study to investigate the role of microbiota and metabolomics in the pathogenesis of PD.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03366740; https://clinicaltrials.gov/ct2/show/NCT03366740.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15759.
背景
腹泻是5岁以下儿童的第二大死因。在低收入和中等收入国家，3% - 20%的急性腹泻发作会发展为持续性腹泻（即病程≥14天），这导致了所有腹泻死亡病例的36% - 56%。在孟加拉国，持续性腹泻导致超过25%的腹泻相关死亡。共生肠道微生物群失调在持续性腹泻的发病机制中越来越受到认可。基于医院的持续性腹泻管理需要住院，这增加了感染风险和医院成本。较高的治疗成本和高病死率再次表明持续性腹泻是一个重要的公共卫生问题。在孟加拉国腹泻病研究国际中心（icddr，b），在过去二十年里，一直遵循基于共识的持续性腹泻指南。观察发现，青香蕉有助于腹泻的缓解。然而，尚未进行更大规模的前瞻性研究来评估青香蕉在6个月以上儿童持续性腹泻管理中的疗效。
目的
我们的目的是在icddr，b达卡医院评估与四分之三强度的米碎粒相比，全强度米碎粒（粗粒小麦粉）加或不加青香蕉在6 - 36个月儿童持续性腹泻管理中的疗效。
方法
这项开放标签、随机对照研究旨在招募总共145名在食用牛奶米碎粒饮食后病情未改善的持续性腹泻儿童。儿童将被随机分为三个不同的特定饮食组：含青香蕉的全强度米碎粒组、单独的全强度米碎粒组和四分之三强度米碎粒组。主要结局是到第5天腹泻恢复的儿童百分比。
结果
招募和数据收集于2017年12月开始，并于2019年11月完成。预计2020年4月得出结果。
结论
本研究有望为将青香蕉纳入持续性腹泻的饮食管理提供见解。这将是第一项研究微生物群和代谢组学在持续性腹泻发病机制中作用的研究。
试验注册
ClinicalTrials.gov NCT03366740；https://clinicaltrials.gov/ct2/show/NCT03366740。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/15759。
Zotero 插件