CompletedPhase 4

Glucomannan for the Treatment of Abdominal Pain-related Functional Gastrointestinal Disorders in Childhood

Poland89 participantsStarted 2010-01

Plain-language summary

Background: Functional abdominal pain disorders (FAPD) are common in school-aged children; however, there is no reliable treatment. Aim: To determine the efficacy and safety of glucomannan for treating FAPD in children. Trial Setting: Department of Pediatrics, The Medical University of Warsaw. Intervention: Patients will be enrolled in a double-blind, randomized controlled trial in which they will receive either glucomannan (10g) or placebo for 4 weeks.

Who can participate

Age range8 Years – 18 Years

SexALL

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: * abdominal pain related disorder (functional dyspepsia, irritable bowel syndrome or functional abdominal pain (FAPS) diagnosed according to Rome III criteria. Exclusion Criteria: * organic gastrointestinal disease (as established by medical history, complete blood count, urinalysis, stool examination for occult blood, ova and parasites, blood chemistries, abdominal ultrasound, breath hydrogen testing and endoscopy, if needed) * other chronic disease * growth failure

What they're measuring

number of patients with no abdominal pain at the end of the study

Timeframe: 4 weeks (study period)

Trial details

NCT IDNCT01495806

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-01

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