The purpose of this study is to determine whether administration of glucomannan (dietary fiber) is effective in treating functional constipation in children.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
1.26 g per sachet; 2 sachets per day for 4 weeks.
prepared in sachets (1.3g); 2 sachets per day for 4 weeks
Department of Paediatrics, The Medical University of Warsaw, Poland
Warsaw, Poland
treatment success
paasing at least 3 stools per week with no episodes of soiling
Time frame: 1 week
stool frequency
number of stools passes per week
Time frame: 1 week
soiling
number of episodes of soiling per week
Time frame: 1 weeks
hard stools or painful defecations
number of hard stools passed or painful defecations per week
Time frame: 1 week
abdominal pain
number of episodes of abdominal pain per week
Time frame: 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)
Time frame: 1 week
flatulence
number of episodes of flatulence per 1 week
Time frame: 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)
Time frame: 4 weeks
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