The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation
- Conditions
- Functional Constipation
- Interventions
- Drug: Local PEG4000Drug: Commercial PEG4000
- Registration Number
- NCT06357897
- Lead Sponsor
- Chulalongkorn University
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 52
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEG-Chula Local PEG4000 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. Standard PEG Commercial PEG4000 Standard PEG (Forlax) is prepared into the sachets labelled A, B, C and D with similar packaging and appearance.
- Primary Outcome Measures
Name Time Method The frequency of stool At 7 days, 14 days, 28 days and 56 days The frequency of stool per day
Stool consistency assessed by Bristol stool chart At 7 days, 14 days, 28 days and 56 days The Bristol stool chart has 7 pictures of stool appearance. The number 1 mean hard stool and number 7 mean watery stool
- Secondary Outcome Measures
Name Time Method Fecal incontinence At 7 days, 14 days, 28 days and 56 days Number of fecal incontinence occurs per day
Adverse events At 7 days, 14 days, 28 days and 56 days Adverse events (i.e diarrhea, abdominal pain, bloating, nausea or vomiting)
Palatability of medication assessed by facial Hedonic scale At 7 days, 14 days, 28 days and 56 days The facial Hedonic scale contains 5 pictures of facial expression and number 1 mean dislike very much while number 5 means like very much
Rectal diameter At 7 days, 14 days, 28 days and 56 days The rectal diameter was measured by abdominal USG
Trial Locations
- Locations (1)
Faculty of Medicine, Chulalongkorn University
🇹🇭Bangkok, Thailand