Skip to main content
OpenTrials
Completed

NCT Number: NCT01151878

Glucomannan for Childhood Functional Constipation.

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Paediatrics, The Medical University of Warsaw, Poland

Warsaw, 01-183, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glucomannan

Dietary Supplement

1.26 g per sachet; 2 sachets per day for 4 weeks.

Other names: Dicoman Junior, Vitis Pharma

Maltodextrin

Dietary Supplement

prepared in sachets (1.3g); 2 sachets per day for 4 weeks

Primary outcomes

  1. treatment success

    Time frame: 1 week

    paasing at least 3 stools per week with no episodes of soiling

Secondary outcomes

  1. stool frequency

    Time frame: 1 week

    number of stools passes per week

  2. soiling

    Time frame: 1 weeks

    number of episodes of soiling per week

  3. hard stools or painful defecations

    Time frame: 1 week

    number of hard stools passed or painful defecations per week

  4. abdominal pain

    Time frame: 1 week

    number of episodes of abdominal pain per week

  5. 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)

  6. flatulence

    Time frame: 1 week

    number of episodes of flatulence per 1 week

  7. 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)

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 29, 2010
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.