Clinical trial NCT03771027: Therapeutic Effect of the Low FODMAP Diet in Children With Functional Abdominal Pain.
Official title: Evaluation of the Effectiveness of the Low FODMAP Diet in the Treatment of Functional Abdominal Pain in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Abdominal Pain Syndrome
Keywords: low FODMAP diet
functional abdominal pain
children
Lead sponsor: University of Warmia and Mazury
Sponsor class: OTHER
Collaborators: name: National Science Centre, Poland
First posted: 2018-12-10
Enrollment: 33
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diet components are important factors in pathogenesis of functional gastrointestinal disorders, especially in the irritable bowel syndrome. Fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) are a group of short chain, poorly absorbed and osmotically active carbohydrates, which can induce gastrointestinal symptoms because of rapid fermentation in different segments of the gut. Low FODMAP diet is a novel treatment option with proven efficacy in reducing symptoms of functional gastrointestinal disorders in adults. Conversely, although functional abdominal pain is a common health problem in children, the efficacy of a low FODMAP diet remains understudied in this population.

The aim of this study was to compare the effects of two diets: a low FODMAP diet and a diet based on standard dietary advice of the National Institute for Health and Care Excellence (NICE), on abdominal symptoms in children with functional abdominal pain.


Eligibility criteria: Inclusion Criteria:

* functional abdominal pain according to Rome III criteria
* consent to participate in the study
* positive decision of gastroenterologist concerning enrolment of the patient to the trial

Exclusion Criteria:

* organic causes for gastrointestinal tract disorders,
* occurrence of an abdominal migraine, IBS, food allergies or intolerances, other significant disorders, acute infection
* antibiotic treatment within the last 8 weeks

Primary outcomes:
measure: Assessment of abdominal pain severity
timeFrame: 6 weeks
Secondary outcomes:
measure: Assessment of abdominal pain and defecation frequency
timeFrame: 6 weeks
Other outcomes:
measure: Assessment of stool consistency
timeFrame: 6 weeks
measure: Assessment of nutritional status
timeFrame: 4 months
measure: Assessment of physical activity
timeFrame: 4 months
measure: Assessment of well-being of the patient
timeFrame: 3 weeks
Locations:
city: Olsztyn
country: Poland
facility: Regional Specialized Children's Hospital
city: Olsztyn
country: Poland
facility: University of Warmia and Mazury
Study officials:
affiliation: Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
name: Katarzyna M Boradyn, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum Faculty of Medicine, University of Warmia and Mazury
name: Elżbieta Jarocka-Cyrta, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
name: Katarzyna E Przybyłowicz, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: