New PEG-based formula to treat children's functional constipation and improve taste
Faculty of Medicine, Chulalongkorn University
NA · Chulalongkorn University · NCT06357897
This trial will test whether a newly developed PEG-based laxative works as well as the standard PEG and whether children find it tastier for treating functional constipation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Sponsor | Chulalongkorn University (other) |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT06357897 on ClinicalTrials.gov |
What this trial studies
Fifty-two children aged 6 months to 18 years with functional constipation will be randomized to receive either a developed PEG formulation (PEG-Chula) or the standard PEG (Forlax) at 0.5–1 g/kg/day for 56 days with identical sachet packaging to maintain blinding. Families will receive the same counseling on toilet training, fluids, and fiber, and parents will record symptoms, intake, and medication in a logbook. Clinical visits occur on days 7, 14, 28, and 56 to collect symptom data, measure stool and rectal diameter by ultrasound, record side effects, and check compliance. Children with poor medication compliance or excluded organic causes of constipation are removed from analysis.
Who should consider this trial
Good fit: Children aged 6 months to 18 years who meet Rome IV criteria for functional constipation and do not have organic causes, bowel obstruction, interfering medications, or allergies to PEG/stevia are ideal candidates.
Not a fit: Children with organic causes of constipation (e.g., Hirschsprung disease), suspected GI obstruction, allergy to PEG or stevia, or who cannot adhere to the dosing/visit schedule are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the new PEG formula could make treatment easier for children by improving taste while providing similar relief from constipation.
How similar studies have performed: Standard PEG formulas are well established as effective for pediatric functional constipation, while reformulations to improve palatability are common though this specific PEG-Chula formula appears novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Children will be enrolled in this study when they meet 2 criteria: * Age from 6 months to 18 years old * Children are diagnosed with FC according to ROME IV criteria Exclusion Criteria: Children will be excluded from the study if they meet any of the following criteria: * Having an organic cause of constipation such as anorectal malformations, Hirschsprung disease, myelomeningocele, hypothyroidism, etc. * Suspected GI obstruction * Receiving medication affecting bowel movement * Having a history of allergy to PEG and stevia.
Where this trial is running
Bangkok
- Faculty of Medicine, Chulalongkorn University — Bangkok, Thailand (RECRUITING)
Study contacts
- Study coordinator: Duc Long Tran, M.D.
- Email: tdlong@ctump.edu.vn
- Phone: +66916668748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Functional Constipation, Functional constipation, Children, Polyethylene glycol, Palatability