Glucomannan for Childhood Functional Constipation. - Full Text View

Purpose

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

Condition	Intervention	Phase
Functional Constipation	Dietary Supplement: Glucomannan Dietary Supplement: maltodextrin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Glucomannan in Treating Childhood Functional Constipation: a Randomized, Double-blind, Placebo-controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Constipation

U.S. FDA Resources

Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:

treatment success [ Time Frame: 1 week ] [ Designated as safety issue: No ]
paasing at least 3 stools per week with no episodes of soiling

Secondary Outcome Measures:

stool frequency [ Time Frame: 1 week ] [ Designated as safety issue: No ]
number of stools passes per week
soiling [ Time Frame: 1 weeks ] [ Designated as safety issue: No ]
number of episodes of soiling per week
hard stools or painful defecations [ Time Frame: 1 week ] [ Designated as safety issue: No ]
number of hard stools passed or painful defecations per week
abdominal pain [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
number of episodes of abdominal pain per week
need for interventional laxative [ Time Frame: 1 week ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
number of episodes of flatulence per 1 week
adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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)

Estimated Enrollment:	80
Study Start Date:	April 2009
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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

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.

Eligibility

Ages Eligible for Study:	3 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151878

Locations

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

Sponsors and Collaborators

Medical University of Warsaw

Investigators

Study Director:

Hania Szajewska, Professor

The Medical University of Warsaw

More Information

Publications:

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. 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. Epub 2008 Aug 19. Review. 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.

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.

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. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Feb 12.

Responsible Party:	Hanna Szajewska, The Medical University of Warsaw
ClinicalTrials.gov Identifier:	NCT01151878 History of Changes
Other Study ID Numbers:	KB/127/2008
Study First Received:	May 7, 2010
Last Updated:	October 27, 2011
Health Authority:	Poland: Ethics Committee Poland: Ministry of Health Poland: Ministry of Science and Higher Education Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland: The Central Register of Clinical Trials

Keywords provided by Medical University of Warsaw:

constipation
children

Additional relevant MeSH terms:

Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
(1-6)-alpha-glucomannan

Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013