An interventional study of Local PEG4000 and Commercial PEG4000 in Functional Constipation, sponsored by Chulalongkorn University. Recruiting at 1 site in Thailand. Open to participants aged 6 Months to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment
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.
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.
Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children will be enrolled in this study when they meet 2 criteria:
Exclusion Criteria:
Children will be excluded from the study if they meet any of the following criteria:
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 (Forlax) is prepared into the sachets labelled A, B, C and D with similar packaging and appearance.
Drug: Commercial 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.
Also known as: PEG-Chula
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
The frequency of stool
The frequency of stool per day
Time frame: 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
Time frame: At 7 days, 14 days, 28 days and 56 days
Fecal incontinence
Number of fecal incontinence occurs per day
Time frame: At 7 days, 14 days, 28 days and 56 days
Rectal diameter measured by transabdominal ultrasonography
Rectal diameter in centimeters is measured by transabdominal ultrasonography.
Time frame: 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.
Time frame: At 7 days, 14 days, 28 days, 56 days and 2 years
Adverse events
Adverse events (i.e diarrhea, abdominal pain, bloating, nausea or vomiting)
Time frame: 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
Time frame: 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.
Time frame: At baseline and 56 days
Plan to share: No — The data were collected anonymous.
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