Glucomannan for Childhood Functional Constipation.

Study Overview
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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.

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.

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

Conditions
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Functional Constipation

Intervention / Treatment
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* Dietary Supplement: Glucomannan
* Dietary Supplement: maltodextrin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucomannan<br>glucomannan preparation in sachets: 1 saschet of 1.26g 2 times per day (daily dosage 2,52g); duration of intervention: 4 weeks | Dietary Supplement: Glucomannan<br>* 1.26 g per sachet; 2 sachets per day for 4 weeks.<br>* Other names: Dicoman Junior, Vitis Pharma;|
| Placebo Comparator: Placebo<br>maltodextrin prepared in sachets (1,3 g per sachet); 2 sachets per day; duration of intervention: 4 weeks | Dietary Supplement: maltodextrin<br>* prepared in sachets (1.3g); 2 sachets per day for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment success | paasing at least 3 stools per week with no episodes of soiling | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stool frequency | number of stools passes per week | 1 week | 
| soiling | number of episodes of soiling per week | 1 weeks | 
| hard stools or painful defecations | number of hard stools passed or painful defecations per week | 1 week | 
| abdominal pain | number of episodes of abdominal pain per week | 1 week | 
| need for interventional laxative | need for rescue treatment (osmotic laxative: lactulose 1 ml of syrup per 1 kg of body weight) when no stool passed for 3 consecutive days) | 1 week | 
| flatulence | number of episodes of flatulence per 1 week | 1 week | 
| adverse events | any adverse events (mild or seriuos) reported by parents during the study period(pain, infections, hospitalizations, accidents or any other event related or not related to study intervention) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation, children