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

Chulalongkorn University

Status: Not yet enrolling

Conditions: Functional Constipation

Treatments: Drug: Commercial PEG4000; Drug: Local PEG4000

Study type: Interventional

Funder types: Other

Identifiers

NCT06357897

0093/67

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups

PEG-Chula

Experimental group

Description:

PEG-Chula is developed from local PEG 4000 used at King Chulalongkorn Memorial Hospital (KCMH) with the addition of sweetener and flavours and prepared into sachets labelled A, B, C and D.

Treatment:

Drug: Local PEG4000

Standard PEG

Other group

Description:

Standard PEG (Forlax) is prepared into the sachets labelled A, B, C and D with similar packaging and appearance.

Treatment:

Drug: Commercial PEG4000