Effect of a Low-FODMAP Diet for the Management of Functional Abdominal Pain Disorders in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in abdominal pain intensity
研究概览
简要总结
This single-center, randomized, controlled, quadruple-blinded, superiority trial is performed to test the hypothesis that children with IBS and FAP-NOS who receive a low-FODMAP diet will have a lower mean abdominal pain intensity score compared with those who receive a regular diet after 4 weeks of intervention.
详细描述
Introduction. 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. However, in children with FAPDs, there is a need for high-quality evidence regarding the dietary management. We aim to assess the effects of a low-FODMAP diet compared with a regular diet for the management of children with FAPDs.
Methods. In this trial, seventy-four children aged 8 to 18 years with a Functional Abdominal Pain Disorder (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.A 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).
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
The research investigators, outcome assessor, and independent statistician (data analyst) will be blinded until the completion of the data analysis.The dietitian will remain unblinded. Success of blinding will be assessed after completion of the follow-up period.
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •functional abdominal pain - not otherwise specified (FAP-NOS) or irritable bowel syndrome (IBS) diagnosed according to the Rome IV Criteria,
- •baseline average pain intensity at least 30 mm on a 100-mm Visual Analogue Scale,
- •feeding via the oral route,
- •ability to read and comprehend any employed questionnaires/scales,
- •signed informed consent,
- •stated availability throughout the study period.
排除标准
- •receiving any other intervention/treatment with regard to FAP-NOS or IBS or those who received any other intervention during the last 3 months,
- •an organic cause of symptoms or organic gastrointestinal disease,
- •chronic illness, receiving medications which affect gastrointestinal motility,
- •need for any other dietary management which could make the balancing or compliance with the diet troublesome,
- •previously diagnosed carbohydrate intolerance without symptoms of FAPD after implementation of an exclusion diet,
- •undernutrition (defined as World Health Organization [WHO] growth charts < -2 SD), decreased growth velocity (sharp decline in growth line), or overweight or obese (> 1 or > 2 SD on the WHO growth charts, respectively),
- •unintentional weight loss greater or equal to 5% of subject' body weight within the previous 3 months,
- •pregnancy,
- •eating disorders,
- •prior surgery of the gastrointestinal tract (within last 3 months),
- •recurrent or unexplained fever,
- •developmental disabilities which impair the ability of the child to understand or communicate.
结局指标
主要结局
Change in abdominal pain intensity
时间窗: At week 1, 2, 3 and 4 from baseline.
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 100-mm 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).
次要结局
- Change in abdominal pain frequency(At week 1, 2, 3 and 4 from baseline.)
- Change in BMI-for-age z-score(At week 2 and 4 from baseline.)
- Change in Gastrointestinal Symptom Rating Scale (GSRS) total score(At week 1, 2, 3 and 4 from baseline.)
- Change in KIDSCREEN-10 index total score(At week 1, 2, 3 and 4 from baseline.)
- Change in percentage of school attendance associated with IBS symptoms(At week 1, 2, 3 and 4 from baseline.)
- Percentage of compliant participants(0-4 weeks.)
- Change in stool consistency(At week 1, 2, 3 and 4 from baseline.)
- Change in World Health Organization Five Well-Being Index (WHO-5) total score(At week 1, 2, 3 and 4 from baseline.)
- Change in percentage of parents' work absenteeism associated with IBS symptoms in child(At week 1, 2, 3 and 4 from baseline.)
- Adverse events(0-4 weeks.)
- Percentage of tolerability of the low-FODMAP diet(0-4 weeks.)