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Effect of a Low-fodmap Diet for the Management of Functional Abdominal Pain Disorders in Children: A Study Protocol for a Randomized Controlled Trial
- Source :
- Nutrition Journal, Nutrition Journal, Vol 20, Iss 1, Pp 1-10 (2021)
- Publication Year :
- 2020
- Publisher :
- Research Square Platform LLC, 2020.
-
Abstract
- BackgroundEvidence 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.MethodsWe 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.DiscussionThere 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 registrationNCT04528914Data and protocol version identifier:24/08/2020
- Subjects :
- Adult
Abdominal pain
medicine.medical_specialty
Visual analogue scale
Oligosaccharides
Medicine (miscellaneous)
lcsh:TX341-641
Disaccharides
law.invention
Irritable Bowel Syndrome
Study Protocol
Diet, Carbohydrate-Restricted
03 medical and health sciences
0302 clinical medicine
Functional abdominal pain disorders
Randomized controlled trial
Rating scale
law
Humans
Medicine
030212 general & internal medicine
Child
Adverse effect
lcsh:RC620-627
Irritable bowel syndrome
Randomized Controlled Trials as Topic
Nutrition and Dietetics
business.industry
Monosaccharides
Dietary management
medicine.disease
Diet
Abdominal Pain
lcsh:Nutritional diseases. Deficiency diseases
Tolerability
Fermentation
Physical therapy
030211 gastroenterology & hepatology
medicine.symptom
business
lcsh:Nutrition. Foods and food supply
RCT
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- Nutrition Journal, Nutrition Journal, Vol 20, Iss 1, Pp 1-10 (2021)
- Accession number :
- edsair.doi.dedup.....cef8c49cda97a332b441bfc99db2f7ed
- Full Text :
- https://doi.org/10.21203/rs.3.rs-73062/v1