Glucomannan for Childhood Functional Constipation.

This study has been completed.
Sponsor:
Information provided by:
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01151878
First received: May 7, 2010
Last updated: October 27, 2011
Last verified: October 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 29, 2014