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Glucomannan for Childhood Functional Constipation.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01151878
First received: May 7, 2010
Last updated: February 22, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: 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.
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 ]
    paasing at least 3 stools per week with no episodes of soiling


Secondary Outcome Measures:
  • 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)


Enrollment: 92
Study Start Date: April 2009
Study Completion Date: June 2010
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   (Child)
Sexes Eligible for Study:   All
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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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: February 22, 2017

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

ClinicalTrials.gov processed this record on July 26, 2017