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

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