Glucomannan for Childhood Functional Constipation.

Phase 3

Completed

• Conditions: Functional Constipation
• Interventions: Dietary Supplement: maltodextrin; Dietary Supplement: Glucomannan

• Registration Number: NCT01151878
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-05-07
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	maltodextrin	maltodextrin prepared in sachets (1,3 g per sachet); 2 sachets per day; duration of intervention: 4 weeks
Glucomannan	Glucomannan	glucomannan preparation in sachets: 1 saschet of 1.26g 2 times per day (daily dosage 2,52g); duration of intervention: 4 weeks

Primary Outcome Measures

Name	Time	Method
treatment success	1 week	paasing at least 3 stools per week with no episodes of soiling

Secondary Outcome Measures

Name	Time	Method
hard stools or painful defecations	1 week	number of hard stools passed or painful defecations per week
stool frequency	1 week	number of stools passes per week
flatulence	1 week	number of episodes of flatulence per 1 week
soiling	1 weeks	number of episodes of soiling per week
abdominal pain	1 week	number of episodes of abdominal pain per week
need for interventional laxative	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)
adverse events	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)

Trial Locations

Locations (1)

Department of Paediatrics, The Medical University of Warsaw, Poland; 🇵🇱 Warsaw, Poland