Therapeutic Effect of the Low FODMAP Diet in Children With Functional Abdominal Pain.

Functional Abdominal Pain Syndrome Clinical Trial

Official title:

Evaluation of the Effectiveness of the Low FODMAP Diet in the Treatment of Functional Abdominal Pain in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771027
• Other study ID #: 2015/17/N/NZ5/02596
• Status: Completed
• Phase: N/A
• Start date: July 8, 2017
• Est. completion date: December 8, 2017

Study information

• Verified date: December 2018
• Source: University of Warmia and Mazury
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 8, 2017
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Functional Abdominal Pain Syndrome

Intervention

Other:
• The low FODMAP diet.
The low FODMAP group had reduced the intake of FODMAP. Children received 3 main meals and 2 snacks daily prepared by the catering company according to the Human Nutrition Recommendations for Polish Population. The dietary intervention lasted four weeks.
• The diet based on NICE guidelines.
The control group based on NICE guidelines received diet contained products with different FODMAP content. Children received 3 main meals and 2 snacks daily prepared by the catering company according to the Human Nutrition Recommendations for Polish Population. The dietary intervention lasted four weeks.

Locations

Country	Name	City	State
Poland	Regional Specialized Children's Hospital	Olsztyn
Poland	University of Warmia and Mazury	Olsztyn

Sponsors (2)

Lead Sponsor	Collaborator
University of Warmia and Mazury	National Science Centre, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of stool consistency	Stool consistency was assessed using the validated Bristol Stool Form Scale. Type 1 or 2 were classified as the hard or lumpy stool, type 6 or 7 as the loose or waterly stool, and type 3-5 as the normal stool.	6 weeks
Other	Assessment of nutritional status	Parameters of nutritional status before diet: weight (kilograms), height (meters).	4 months
Other	Assessment of physical activity	The level of physical activity was established used the MVPA indicator (Moderate to Vigorous Physical Activity)	4 months
Other	Assessment of well-being of the patient	Declarations of parents about symptoms changes in children during diet intervention based on a seven-point Likert scale (from 'much worse' to 'never occurred')	3 weeks
Primary	Assessment of abdominal pain severity	Wong-Baker FACES Pain Rating Scale where 0 = no hurt and 10 = hurts worst was used for assessed severity of abdominal pain during the 6-week study period (2 weeks before and 4 weeks during the diet)	6 weeks
Secondary	Assessment of abdominal pain and defecation frequency	Abdominal pain and defecation frequency were recorded as number per day.	6 weeks