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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03771027
Other study ID # 2015/17/N/NZ5/02596
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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