Glucomannan for Childhood Functional Constipation.

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

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

Study Overview

• Status: Completed
• Conditions: Functional Constipation
• Intervention / Treatment: Dietary supplement: Glucomannan; Dietary supplement: maltodextrin

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-183
    • Department of Paediatrics, The Medical University of Warsaw, Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glucomannan; 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 Names: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Study Director: Hania Szajewska, Professor, The Medical University of Warsaw

Publications and helpful links

General Publications

• Hyman PE, Milla PJ, Benninga MA, Davidson GP, Fleisher DF, Taminiau J. Childhood functional gastrointestinal disorders: neonate/toddler. Gastroenterology. 2006 Apr;130(5):1519-26. doi: 10.1053/j.gastro.2005.11.065.
• Belsey J, Greenfield S, Candy D, Geraint M. Systematic review: impact of constipation on quality of life in adults and children. Aliment Pharmacol Ther. 2010 May;31(9):938-49. doi: 10.1111/j.1365-2036.2010.04273.x. Epub 2010 Feb 20.
• Pijpers MA, Tabbers MM, Benninga MA, Berger MY. Currently recommended treatments of childhood constipation are not evidence based: a systematic literature review on the effect of laxative treatment and dietary measures. Arch Dis Child. 2009 Feb;94(2):117-31. doi: 10.1136/adc.2007.127233. Epub 2008 Aug 19. Erratum In: Arch Dis Child. 2009 Aug;94(8):649.
• Loening-Baucke V, Miele E, Staiano A. Fiber (glucomannan) is beneficial in the treatment of childhood constipation. Pediatrics. 2004 Mar;113(3 Pt 1):e259-64. doi: 10.1542/peds.113.3.e259.
• Staiano A, Simeone D, Del Giudice E, Miele E, Tozzi A, Toraldo C. Effect of the dietary fiber glucomannan on chronic constipation in neurologically impaired children. J Pediatr. 2000 Jan;136(1):41-5. doi: 10.1016/s0022-3476(00)90047-7.
• Chmielewska A, Horvath A, Dziechciarz P, Szajewska H. Glucomannan is not effective for the treatment of functional constipation in children: a double-blind, placebo-controlled, randomized trial. Clin Nutr. 2011 Aug;30(4):462-8. doi: 10.1016/j.clnu.2011.01.012. Epub 2011 Feb 12.

Helpful Links

• Rome Criteria III

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: June 28, 2010
• First Posted (Estimate): June 29, 2010

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: children; constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Gastrointestinal Agents; Cathartics; (1-6)-alpha-glucomannan
• Other Study ID Numbers: KB/127/2008