ConditionFunctional Constipation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorChulalongkorn University
About this trial
This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Besides, we also aim to assess the side effects of a developed PEG-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups.
Eligibility criteria
Qualifiers
Age from 6 months to 18 years old
Children are diagnosed with FC according to ROME IV criteria
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Local PEG4000
- Commercial PEG4000
Treatment groups
52 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov