The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation

Total 52 children age 6 months to 18 years old diagnosed with functional constipation will be enrolled in this study. They will be randomised in Group A or Group B.

Children in group A will receive PEG-Chula at a dose of 0.5 - 1 g/kg/day for a duration of 56 days.

Children in group B will receive the standard PEG formula (Forlax) at a dose of 0.5 - 1 g/kg/day for a duration of 56 days.

PEG-Chula and standard PEG will be prepared in sachets with similar packaging and appearance labelled A, B, C, D.

Children in both groups will also receive counseling on toilet training, water intake, and fiber intake in the same manner.

Parents will be advised to record symptoms, dietary intake, and dose of medication in a logbook.

Children will visit the researchers on days 7, 14, 28, and 56 to collect data on symptoms, stool diameter, bowel size measured by ultrasound, side effects, and medication compliance. Children with poor compliance will be excluded from the study.

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.