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Completed

NCT Number: NCT03771027

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

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.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Specialized Children's Hospital, Olsztyn, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The low FODMAP diet.

Other

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.

Other

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.

Primary outcomes

  1. Assessment of abdominal pain severity

    Time frame: 6 weeks

    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)

Secondary outcomes

  1. Assessment of abdominal pain and defecation frequency

    Time frame: 6 weeks

    Abdominal pain and defecation frequency were recorded as number per day.

Other outcomes

  1. Assessment of stool consistency

    Time frame: 6 weeks

    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.

  2. Assessment of nutritional status

    Time frame: 4 months

    Parameters of nutritional status before diet: weight (kilograms), height (meters).

  3. Assessment of physical activity

    Time frame: 4 months

    The level of physical activity was established used the MVPA indicator (Moderate to Vigorous Physical Activity)

  4. Assessment of well-being of the patient

    Time frame: 3 weeks

    Declarations of parents about symptoms changes in children during diet intervention based on a seven-point Likert scale (from 'much worse' to 'never occurred')

Sponsors and collaborators

Lead sponsor

University of Warmia and Mazury

Other

Collaborators

  • National Science Centre, Poland

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 10, 2018
Registry last updated
Dec 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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