Actively Recruiting
The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation
Led by Chulalongkorn University · Updated on 2026-04-02
52
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and taste of a newly developed polyethylene glycol (PEG)-based formula compared to the standard PEG formula in treating children with functional constipation. This study includes children aged 6 months to 18 years diagnosed with functional constipation based on ROME IV criteria. The study also aims to assess side effects and changes in rectal diameter over time between the two treatment groups. Participants will be randomly assigned to one of two groups: Group A will receive the developed PEG-Chula formula, which includes sweeteners and flavors, at a dose of 0.5 to 1 g/kg/day for 56 days. Group B will receive the standard PEG formula (Forlax) at the same dose and duration. Both treatments come in similar sealed sachets to ensure blinding. Throughout the study, all children will receive counseling on toilet training, water intake, and fiber intake. Children will visit the researchers on days 7, 14, 28, and 56 to monitor symptoms, stool frequency and consistency, bowel size via ultrasound, side effects, and medication adherence. Parents will keep a logbook of symptoms, diet, and medication doses. The primary outcomes measured include stool frequency and consistency, while secondary outcomes include fecal incontinence, rectal measurements, palatability assessed by a facial Hedonic scale, adverse events, and gut microbiota changes. Monitoring will continue up to 2 years for some measures. Children with poor adherence may be excluded from the study.
CONDITIONS
Brief Title
The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 months to 18 years
- Diagnosed with functional constipation according to ROME IV criteria
You will not qualify if you...
- Having an organic cause of constipation such as anorectal malformations, Hirschsprung disease, myelomeningocele, or hypothyroidism
- Suspected gastrointestinal obstruction
- Receiving medication affecting bowel movement
- History of allergy to polyethylene glycol (PEG) or stevia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 56 days
Participants receive either the PEG-Chula formula or the standard PEG formula daily for 56 days. They also receive counseling on toilet training, water intake, and fiber intake.
Visits on days 7, 14, 28, and 56
Trial Site Locations
Total: 1 location
1
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
Actively Recruiting
Research Team
D
Duc Long Tran, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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