Glucomannan for Childhood Functional Constipation.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-06-30

Brief Summary

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

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Detailed Description

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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

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Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The participants and researchers conducting the study were blinded. Intervention products were prepared in sachets centrally by the hospital pharmacy by a person not involved in the conduct of the trial. The active product and placebo were packaged in identical sachets and labeled with one of two codes, each allocated to the experimental product or placebo. This procedure was performed by an independent pharmacist, who was the only person aware of the codes' meaning. The appearance and texture of the dry products were identical.

Study Groups

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Glucomannan

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

Group Type EXPERIMENTAL

Glucomannan

Intervention Type DIETARY_SUPPLEMENT

1.26 g per sachet; 2 sachets per day for 4 weeks.

Placebo

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

Group Type PLACEBO_COMPARATOR

maltodextrin

Intervention Type DIETARY_SUPPLEMENT

prepared in sachets (1.3g); 2 sachets per day for 4 weeks

Interventions

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Glucomannan

1.26 g per sachet; 2 sachets per day for 4 weeks.

Intervention Type DIETARY_SUPPLEMENT

maltodextrin

prepared in sachets (1.3g); 2 sachets per day for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Dicoman Junior, Vitis Pharma

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No