New PEG-based formula to treat children's functional constipation and improve taste

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Faculty of Medicine, Chulalongkorn University
  Bangkok, Thailand Recruiting

Study contacts

• Study coordinator: Duc Long Tran, M.D.
• Email: tdlong@ctump.edu.vn
• Phone: +66916668748

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.