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

Faculty of Medicine, Chulalongkorn University

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.

Study Overview

• Status: Recruiting
• Conditions: Functional Constipation
• Intervention / Treatment: Drug: Local PEG4000; Drug: Commercial PEG4000

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Duc Long Tran, M.D.; Phone Number: +66916668748; Email: tdlong@ctump.edu.vn

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • Faculty of Medicine, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEG-Chula; 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.	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.; Other Names: PEG-Chula
Other: Standard PEG; Standard PEG (Forlax) is prepared into the sachets labelled A, B, C and D with similar packaging and appearance.	Drug: 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.; Other Names: Forlax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of stool	The frequency of stool per day	At 7 days, 14 days, 28 days and 56 days
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal incontinence	Number of fecal incontinence occurs per day	At 7 days, 14 days, 28 days and 56 days
Adverse events	Adverse events (i.e diarrhea, abdominal pain, bloating, nausea or vomiting)	At 7 days, 14 days, 28 days and 56 days
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
Change of gut microbiota before and after treatment	Stools is collected before treatment at baseline and at the end of treatment. Gut microbiota was analyzed by Nanopore technique.	At baseline and 56 days
Rectal diameter measured by transabdominal ultrasonography	Rectal diameter in centimeters is measured by transabdominal ultrasonography.	At 7 days, 14 days, 28 days, 56 days and 2 years
Anterior wall thickness measured by transabdominal ultrasonography	Anterior wall thickness in centimeters is measured by transabdominal ultrasonography.	At 7 days, 14 days, 28 days, 56 days and 2 years

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Study Chair: Palittiya Sintusek, Ph.D., Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Children; Palatability; Polyethylene glycol; Functional constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 0093/67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data were collected anonymous.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No