Low-FODMAP Diet for Functional Abdominal Pain Disorders in Children. (NCT04528914) | Clinical Trial Compass
TerminatedNot Applicable
Low-FODMAP Diet for Functional Abdominal Pain Disorders in Children.
Stopped: Preliminary results found that there is no difference on abdominal pain intensity between low-FODMAP and regular diet at 4 weeks. Moreover, both diets were difficult to adhere by patients. We do not expect any significant change in our findings.
Poland42 participantsStarted 2023-04-02
Plain-language summary
This single-center, randomized, controlled, quadruple-blinded, superiority trial is performed to test the hypothesis that children with IBS and FAP-NOS who receive a low-FODMAP diet will have a lower mean abdominal pain intensity score compared with those who receive a regular diet after 4 weeks of intervention.
Who can participate
Age range8 Years – 18 Years
SexALL
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Inclusion Criteria:
* functional abdominal pain - not otherwise specified (FAP-NOS) or irritable bowel syndrome (IBS) diagnosed according to the Rome IV Criteria,
* baseline average pain intensity at least 30 mm on a 100-mm Visual Analogue Scale,
* feeding via the oral route,
* ability to read and comprehend any employed questionnaires/scales,
* signed informed consent,
* stated availability throughout the study period.
Exclusion Criteria:
* receiving any other intervention/treatment with regard to FAP-NOS or IBS or those who received any other intervention during the last 3 months,
* an organic cause of symptoms or organic gastrointestinal disease,
* chronic illness, receiving medications which affect gastrointestinal motility,
* need for any other dietary management which could make the balancing or compliance with the diet troublesome,
* previously diagnosed carbohydrate intolerance without symptoms of FAPD after implementation of an exclusion diet,
* undernutrition (defined as World Health Organization \[WHO\] growth charts \< -2 SD), decreased growth velocity (sharp decline in growth line), or overweight or obese (\> 1 or \> 2 SD on the WHO growth charts, respectively),
* unintentional weight loss greater or equal to 5% of subject' body weight within the previous 3 months,
* pregnancy,
* eating disorders,
* prior surgery of the gastrointestinal tract (within last 3 months),
* recurrent or unexplained fever,
* developmental disabilities which impair the ability of the …