Glucomannan for Childhood Functional Constipation.

Functional Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151878
• Other study ID #: KB/127/2008
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2010
• Last updated: February 22, 2017
• Start date: April 2009
• Est. completion date: June 2010

Study information

• Verified date: February 2017
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Dietary Supplement:
• Glucomannan
1.26 g per sachet; 2 sachets per day for 4 weeks.
• maltodextrin
prepared in sachets (1.3g); 2 sachets per day for 4 weeks

Locations

Country	Name	City	State
Poland	Department of Paediatrics, The Medical University of Warsaw, Poland	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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- — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment success	paasing at least 3 stools per week with no episodes of soiling	1 week
Secondary	stool frequency	number of stools passes per week	1 week
Secondary	soiling	number of episodes of soiling per week	1 weeks
Secondary	hard stools or painful defecations	number of hard stools passed or painful defecations per week	1 week
Secondary	abdominal pain	number of episodes of abdominal pain per week	1 week
Secondary	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
Secondary	flatulence	number of episodes of flatulence per 1 week	1 week
Secondary	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

External Links

•   Rome Criteria III