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 range

8 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in abdominal pain intensity

Timeframe: At week 1, 2, 3 and 4 from baseline.

Trial details

NCT IDNCT04528914

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Functional Abdominal Pain Disorder trials