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低 FODMAP 饮食治疗儿童功能性腹痛障碍的效果:一项随机对照试验的研究方案。

Effect of a low-FODMAP diet for the management of functional abdominal pain disorders in children: a study protocol for a randomized controlled trial.

机构信息

Department of Paediatrics, The Medical University of Warsaw, Żwirki i Wigury 63A, 02-091, Warsaw, Poland.

Department of Gastroenterology, Monash University, Melbourne, Victoria, Australia.

出版信息

Nutr J. 2021 Jan 2;20(1):1. doi: 10.1186/s12937-020-00656-3.


DOI:10.1186/s12937-020-00656-3
PMID:33388067
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7778810/
Abstract

BACKGROUND: Evidence from studies in adults documents that fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) may be triggers of symptoms in individuals with functional abdominal pain disorders (FAPDs). However, in children, the evidence is very limited. We aim to assess the effects of a low-FODMAP diet compared with a regular diet for the management of children with FAPDs. METHODS: We will perform a randomized, quadruple-blinded, controlled trial. Seventy-four children aged 8 to 18 years with a FAPD (Irritable Bowel Syndrome or Functional Abdominal Pain-Not Otherwise Specified), diagnosed according to the Rome IV criteria, will be randomly allocated to receive either a low-FODMAP diet or a regular diet for 4 weeks. The primary outcome will be the percentage of the responders, defined as the participants who have at least 30% improvement in abdominal pain intensity on a Visual Analogue Scale (VAS) during the last week of the trial compared with baseline, that is at least equal to the Reliable Change Index (≥ 25 mm change on VAS). Other outcomes will include changes in stool consistency, abdominal pain frequency, total scores on the Gastrointestinal Symptom Rating Scale, KIDSCREEN-10 Index and World Health Organization Five Well-Being Index, child's school attendance and parents' work absenteeism, and BMI-for-age z-score. Compliance, tolerability of the low-FODMAP diet, and adverse events also will be evaluated. Each FAPD subtype will be assessed separately. DISCUSSION: There is a need for high-quality evidence regarding the dietary management of children with FAPDs. This randomized controlled trial (RCT) of rigorous methodological design will help to establish the effectiveness, if any, of a low-FODMAP diet for the management of FAPDs in the pediatric population. The findings of this RCT will assist with the development of guidelines and influence the direction of further research. TRIAL REGISTRATION: NCT04528914 Data and protocol version identifier: 24/08/2020.

摘要

背景:成人研究的证据表明,可发酵的低聚糖、双糖、单糖和多元醇(FODMAP)可能是功能性腹痛障碍(FAPD)患者症状的触发因素。然而,在儿童中,证据非常有限。我们旨在评估低 FODMAP 饮食与常规饮食相比在管理 FAPD 儿童中的效果。

方法:我们将进行一项随机、四盲、对照试验。74 名年龄在 8 至 18 岁之间的 FAPD(肠易激综合征或功能性腹痛-未另作说明)儿童,根据罗马 IV 标准诊断,将被随机分配接受低 FODMAP 饮食或常规饮食 4 周。主要结局将是应答者的百分比,定义为在试验的最后一周与基线相比,腹痛强度的视觉模拟量表(VAS)至少改善 30%,即至少等于可靠变化指数(VAS 上至少 25 毫米的变化≥25 毫米)。其他结局包括粪便稠度、腹痛频率、胃肠道症状评定量表、KIDSCREEN-10 指数和世界卫生组织五项福祉指数的总分、儿童出勤率和家长缺勤率以及 BMI 年龄 z 评分的变化。还将评估依从性、低 FODMAP 饮食的耐受性和不良事件。将分别评估每种 FAPD 亚型。

讨论:需要高质量的证据来确定 FAPD 儿童的饮食管理方法。这项方法严谨的随机对照试验(RCT)将有助于确定低 FODMAP 饮食对儿科人群 FAPD 管理的有效性。该 RCT 的结果将有助于制定指南,并影响进一步研究的方向。

试验注册:NCT04528914 数据和方案版本标识符:2020 年 8 月 24 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aec9/7778810/79006d55fbe2/12937_2020_656_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aec9/7778810/79006d55fbe2/12937_2020_656_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aec9/7778810/79006d55fbe2/12937_2020_656_Fig1_HTML.jpg

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本文引用的文献

[1]
A Core Outcome Set for Clinical Trials in Pediatric Functional Abdominal Pain Disorders.

J Pediatr. 2020-4-17

[2]
Randomised clinical trial: reducing the intake of dietary FODMAPs of breastfeeding mothers is associated with a greater improvement of the symptoms of infantile colic than for a typical diet.

Aliment Pharmacol Ther. 2018-10-10

[3]
The low FODMAP diet in the management of irritable bowel syndrome: an evidence-based review of FODMAP restriction, reintroduction and personalisation in clinical practice.

J Hum Nutr Diet. 2018-1-15

[4]
When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts.

BMC Med Res Methodol. 2017-12-6

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Diagnosis and management of irritable bowel syndrome: a guide for the generalist.

Med J Aust. 2017-9-2

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Low-FODMAP Diet Improves Irritable Bowel Syndrome Symptoms: A Meta-Analysis.

Nutrients. 2017-8-26

[7]
Low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet improves symptoms in adults suffering from irritable bowel syndrome (IBS) compared to standard IBS diet: A meta-analysis of clinical studies.

PLoS One. 2017-8-14

[8]
Systematic review: quality of trials on the symptomatic effects of the low FODMAP diet for irritable bowel syndrome.

Aliment Pharmacol Ther. 2017-4-25

[9]
Dietary interventions for recurrent abdominal pain in childhood.

Cochrane Database Syst Rev. 2017-3-23

[10]
FODMAPs: food composition, defining cutoff values and international application.

J Gastroenterol Hepatol. 2017-3

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