Glucomannan for Childhood Functional Constipation.

NCT01151878 | Completed Phase 3

• 1 other identifier: KB/127/2008
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Constipation

Keywords

constipation; children

Outcome Measures

Primary Outcomes (1)

• treatment success

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

  1 week

Secondary Outcomes (7)

• stool frequency

  1 week

• soiling

  1 weeks

• hard stools or painful defecations

  1 week

• abdominal pain

  1 week

• need for interventional laxative

  1 week

Study Arms (2)

Glucomannan

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

maltodextrin prepared in sachets (1,3 g per sachet); 2 sachets per day; duration of intervention: 4 weeks

Dietary Supplement: maltodextrin

Interventions

Glucomannan DIETARY_SUPPLEMENT

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

Also known as: Dicoman Junior, Vitis Pharma

Glucomannan

maltodextrin DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 3 to 16 years
• informed consent from parents and/or child

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Paediatrics, The Medical University of Warsaw, Poland

Warsaw, 01-183, Poland

Location

Related Publications (6)

• 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. doi: 10.1053/j.gastro.2005.11.065.

  PMID: 16678565 BACKGROUND

• 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. Epub 2010 Feb 20.

  PMID: 20180788 RESULT

• 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. doi: 10.1136/adc.2007.127233. Epub 2008 Aug 19.

  PMID: 18713795 RESULT

• 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. doi: 10.1542/peds.113.3.e259.

  PMID: 14993586 RESULT

• 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. doi: 10.1016/s0022-3476(00)90047-7.

  PMID: 10636972 RESULT

• 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. doi: 10.1016/j.clnu.2011.01.012. Epub 2011 Feb 12.

  PMID: 21320737 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

(1-6)-alpha-glucomannan; maltodextrin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hania Szajewska, Professor

  The Medical University of Warsaw

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: June 29, 2010
• Study Start: April 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 24, 2017

Record last verified: 2017-02

Locations

PL (1)