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.
Age from 6 months to 18 years old
Children are diagnosed with FC according to ROME IV 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.
Parallel
Local PEG4000
DrugPEG-Chula is developed from PEG 4000 used at King Chulalongkorn Memorial Hospital with added sweetener and flavours. Children will be given PEG-Chula at a dose of 0.5 - 1 g/kg/day.
Commercial PEG4000
DrugFor commercial PEG, We use Forlax as the control group. Children will be given Forlax at a dose of 0.5 - 1 g/kg/day.
The frequency of stool
The frequency of stool per day
Stool consistency assessed by Bristol stool chart
The Bristol stool chart has 7 pictures of stool appearance. The number 1 mean hard stool and number 7 mean watery stool
Fecal incontinence
Number of fecal incontinence occurs per day
Rectal diameter measured by transabdominal ultrasonography
Rectal diameter in centimeters is measured by transabdominal ultrasonography.
Anterior wall thickness measured by transabdominal ultrasonography
Anterior wall thickness in centimeters is measured by transabdominal ultrasonography.
Adverse events
Adverse events (i.e diarrhea, abdominal pain, bloating, nausea or vomiting)
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