Glucomannan for Childhood Functional Constipation.
|ClinicalTrials.gov Identifier: NCT01151878|
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : February 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Functional Constipation||Dietary Supplement: Glucomannan Dietary Supplement: maltodextrin||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Glucomannan in Treating Childhood Functional Constipation: a Randomized, Double-blind, Placebo-controlled Trial.|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
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
1.26 g per sachet; 2 sachets per day for 4 weeks.
Other Name: Dicoman Junior, Vitis Pharma
Placebo Comparator: Placebo
maltodextrin prepared in sachets (1,3 g per sachet); 2 sachets per day; duration of intervention: 4 weeks
Dietary Supplement: maltodextrin
prepared in sachets (1.3g); 2 sachets per day for 4 weeks
- treatment success [ Time Frame: 1 week ]paasing at least 3 stools per week with no episodes of soiling
- stool frequency [ Time Frame: 1 week ]number of stools passes per week
- soiling [ Time Frame: 1 weeks ]number of episodes of soiling per week
- hard stools or painful defecations [ Time Frame: 1 week ]number of hard stools passed or painful defecations per week
- abdominal pain [ Time Frame: 1 week ]number of episodes of abdominal pain per week
- need for interventional laxative [ 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)
- flatulence [ Time Frame: 1 week ]number of episodes of flatulence per 1 week
- adverse events [ 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151878
|Department of Paediatrics, The Medical University of Warsaw, Poland|
|Warsaw, Poland, 01-183|
|Study Director:||Hania Szajewska, Professor||The Medical University of Warsaw|