Polyethylene Glycol for Childhood Constipation
1 other identifier
interventional
90
1 country
1
Brief Summary
Background: Aim: Clinical evaluation of the effectiveness of two different polyethylene glycol doses for the maintenance treatment of functional constipation in children. Study design: Randomized, open-label trial. Randomized, double-blind, placebo controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 6, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2013
CompletedJuly 22, 2025
July 1, 2025
5 months
June 6, 2013
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
therapeutic success (passing ≥ 3 stools per week, with no loosening of stool).
the number and consistency of the stool will be recorded at 6th week of intervention
Secondary Outcomes (6)
the number of stools delivered at 6th week of intervention
the number of the stools will be recorded at the 6th week of intervention
the number of incontinence episodes
the number of the incontinence episodes will be recorded at the 6th week of intervention
the number of painful defecation
the number of painful defecation will be recorded at the 6th week of intervention
the number of episodes of abdominal pain
the number of the episodes of abdominal pain will be recorded at the 6th week of intervention
the number of patients needed laxatives during treatment
the number patiens needed laxatives will be recorded for six weeks of intervention
- +1 more secondary outcomes
Study Arms (2)
Polyethylene glycol small dose
EXPERIMENTALPolyethylene glycol 4000: 0.3 g/kg/day for 6 weeks
Polyethylene glycol high dose
ACTIVE COMPARATORPolyethylene glycol 4000: 0.7g/kg for 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- age 1 - 18 age
- functional constipation according to the Rome III Criteria
- consent of parents or guardians of the child to participate and study
You may not qualify if:
- organic cause constipation (including surgeries within the lower GI tract)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dpt of Pediatrics The Medical University of Warsaw
Warsaw, 01-184, Poland
Related Publications (1)
Dziechciarz P, Horvath A, Szajewska H. Polyethylene glycol 4000 for treatment of functional constipation in children. J Pediatr Gastroenterol Nutr. 2015 Jan;60(1):65-8. doi: 10.1097/MPG.0000000000000543.
PMID: 25162362DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Horvath, MD
Medical University of Warsaw
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
June 6, 2013
First Posted
June 12, 2013
Study Start
June 1, 2013
Primary Completion
November 1, 2013
Study Completion
November 30, 2013
Last Updated
July 22, 2025
Record last verified: 2025-07