Glucomannan for Childhood Functional Constipation.

Medical University of Warsaw

Status and phase: Completed; Phase 3

Conditions: Functional Constipation

Treatments: Dietary Supplement: maltodextrin; Dietary Supplement: Glucomannan

Study type: Interventional

Funder types: Other

Identifiers

NCT01151878

KB/127/2008

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• functional constipation diagnosed according to Rome Criteria III (duration of symptoms for at least 2 months prior to study inclusion)
• age 3 to 16 years
• informed consent from parents and/or child

Exclusion criteria

• organic cause of defecation disorders (Hirschsprung's disease, spinal anomalies or anorectal pathology; history of gastro-intestinal surgery)
• mental retardation
• metabolic disease (e.g. hypothyroidism)
• irritable bowel syndrome
• intake of medications influencing gastrointestinal motility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 2 patient groups, including a placebo group

Glucomannan

Experimental group

Description:

glucomannan preparation in sachets: 1 saschet of 1.26g 2 times per day (daily dosage 2,52g); duration of intervention: 4 weeks

Treatment:

Dietary Supplement: Glucomannan

Placebo

Placebo Comparator group

Description:

maltodextrin prepared in sachets (1,3 g per sachet); 2 sachets per day; duration of intervention: 4 weeks

Treatment:

Dietary Supplement: maltodextrin