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

Functional Constipation Clinical Trial

Official title:

Faculty of Medicine, Chulalongkorn University

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06357897
• Other study ID #: 0093/67
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Chulalongkorn University
• Contact: Duc Long Tran, M.D.
• Phone: +66916668748
• Email: tdlong[@]ctump.edu.vn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: June 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Drug:
• Local PEG4000
PEG-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
For commercial PEG, We use Forlax as the control group. Children will be given Forlax at a dose of 0.5 - 1 g/kg/day.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of stool	The frequency of stool per day	At 7 days, 14 days, 28 days and 56 days
Primary	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	At 7 days, 14 days, 28 days and 56 days
Secondary	Fecal incontinence	Number of fecal incontinence occurs per day	At 7 days, 14 days, 28 days and 56 days
Secondary	Rectal diameter	The rectal diameter was measured by abdominal USG	At 7 days, 14 days, 28 days and 56 days
Secondary	Adverse events	Adverse events (i.e diarrhea, abdominal pain, bloating, nausea or vomiting)	At 7 days, 14 days, 28 days and 56 days
Secondary	Palatability of medication assessed by facial Hedonic scale	The facial Hedonic scale contains 5 pictures of facial expression and number 1 mean dislike very much while number 5 means like very much	At 7 days, 14 days, 28 days and 56 days