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

NCT06357897 | Recruiting

• 1 other identifier: 0093/67
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Constipation

Keywords

Functional constipation; Children; Polyethylene glycol; Palatability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Fecal incontinence

  At 7 days, 14 days, 28 days and 56 days

• Rectal diameter measured by transabdominal ultrasonography

  At 7 days, 14 days, 28 days, 56 days and 2 years

• Anterior wall thickness measured by transabdominal ultrasonography

  At 7 days, 14 days, 28 days, 56 days and 2 years

• Adverse events

  At 7 days, 14 days, 28 days and 56 days

• Palatability of medication assessed by facial Hedonic scale

  At 7 days, 14 days, 28 days and 56 days

Study Arms (2)

PEG-Chula

EXPERIMENTAL

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

Standard PEG

OTHER

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

Drug: Commercial PEG4000

Interventions

Local PEG4000 DRUG

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.

Also known as: PEG-Chula

PEG-Chula

Commercial PEG4000 DRUG

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.

Also known as: Forlax

Standard PEG

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

RECRUITING

Study Officials

• Palittiya Sintusek, Ph.D.

  Chulalongkorn University

  STUDY CHAIR

Central Study Contacts

Duc Long Tran, M.D.

CONTACT

+66916668748; tdlong@ctump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The intervention and control were prepared in the similar sachet and was blinded to investigatiors, participants and guardians
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator of Center of Excellence in Clinical Virology, Faculty of Medicine

Model Details: Intervention group received PEG-Chula Control group received Forlax

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: May 3, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)