NCT01151878

Glucomannan for Childhood Functional Constipation.

Glucomannan in Treating Childhood Functional Constipation: a Randomized, Double-blind, Placebo-controlled Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 3 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether administration of glucomannan (dietary fiber) is effective in treating functional constipation in children.

Detailed description

Constipation is a common condition in children. In many patients symptoms persist to adulthood and decrease quality of life. The standard treatment, mostly osmotic laxatives such as lactulose or polyethyleneglycols, are often ineffective and may cause adverse events. Therefore, alternative treatment measures are being searched for. Glucomannan, a water-soluble fiber polysaccharide from the tubers of the Japanese Konjac plant, has been reported to be effective in constipated children. To date, 2 randomized trials were performed.1,2 One evaluated the effect as glucomannan as an adjunct to standard treatment.1 Another was conducted in neurologically impaired children, who constitute a specific population that cannot be compared to patients with functional constipation.2 In both trials, the number of patients was relatively small. Well-powered, randomized controlled study is required to evaluate clinical effectiveness of glucomannan as a sole treatment in childhood functional constipation.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Glucomannan	1.26 g per sachet; 2 sachets per day for 4 weeks.
DIETARY_SUPPLEMENT	maltodextrin	prepared in sachets (1.3g); 2 sachets per day for 4 weeks

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-06-29
• Last updated: 2017-02-24

Locations

1 site across 1 country: Poland