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

NCT01495806 | Completed Phase 4

• 1 other identifier: 2010
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Gastrointestinal Disorders

Keywords

functional dyspepsia; irritable bowel syndrome; functional abdominal pain

Outcome Measures

Primary Outcomes (1)

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

  4 weeks (study period)

Secondary Outcomes (5)

• number of patients with improvement in self-reported severity of pain

  4 weeks study period

• number of patients suffered from abdominal pain < 1/week

  4 weeks (during the study period)

• number of patients who used medication for abdominal pain

  4 weeks study period

• number of patients who lost min.1 school day because of abdominal pain

  4 weeks (study period)

• Number of participants with adverse events as a measure of safety and tolerability

  participants will be followed for the duration of h an expected average of 4 weeks - study period

Study Arms (2)

Glucomannan

EXPERIMENTAL

5 g 2x 10 day

Drug: Glucomannan

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Glucomannan DRUG

2 x 5g

Glucomannan

placebo DRUG

glucose 5 g

Placebo

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• abdominal pain related disorder (functional dyspepsia, irritable bowel syndrome or functional abdominal pain (FAPS) diagnosed according to Rome III criteria.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Dpt of Pediatrics Warsaw Medical University

Warsaw, Warsaw, 01-410, Poland

Location

Related Publications (1)

• Horvath A, Dziechciarz P, Szajewska H. Glucomannan for abdominal pain-related functional gastrointestinal disorders in children: a randomized trial. World J Gastroenterol. 2013 May 28;19(20):3062-8. doi: 10.3748/wjg.v19.i20.3062.

  PMID: 23716985 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases; Irritable Bowel Syndrome

Interventions

(1-6)-alpha-glucomannan

Condition Hierarchy (Ancestors)

Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases

Study Officials

• Andrea Horvath, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: December 20, 2011
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

PL (1)