Department of Paediatrics, The Medical University of Warsaw, Poland
Warsaw, 01-183, Poland
NCT Number: NCT01151878
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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Notify Me3 year–16 year
All sexes
Interventional
Phase 3
Warsaw, 01-183, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.26 g per sachet; 2 sachets per day for 4 weeks.
Other names: Dicoman Junior, Vitis Pharma
prepared in sachets (1.3g); 2 sachets per day for 4 weeks
Time frame: 1 week
paasing at least 3 stools per week with no episodes of soiling
Time frame: 1 week
number of stools passes per week
Time frame: 1 weeks
number of episodes of soiling per week
Time frame: 1 week
number of hard stools passed or painful defecations per week
Time frame: 1 week
number of episodes of abdominal pain per week
Time frame: 1 week
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)
Time frame: 1 week
number of episodes of flatulence per 1 week
Time frame: 4 weeks
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)
Medical University of Warsaw
Other
Glucomannan in Treating Childhood Functional Constipation: a Randomized, Double-blind, Placebo-controlled Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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