The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation
NCT ID: NCT06357897
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
52 participants
INTERVENTIONAL
2024-05-31
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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.
Standard PEG
Standard PEG (Forlax) is prepared into the sachets labelled A, B, C and D with similar packaging and appearance.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age from 6 months to 18 years old
* Children are diagnosed with FC according to ROME IV criteria
Exclusion 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.
6 Months
18 Years
ALL
Yes
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Duc Long Tran
Principal investigator of Center of Excellence in Clinical Virology, Faculty of Medicine
Principal Investigators
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Palittiya Sintusek, Ph.D.
Role: STUDY_CHAIR
Chulalongkorn University
Locations
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Faculty of Medicine, Chulalongkorn University
Bangkok, , Thailand
Countries
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Central Contacts
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Other Identifiers
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0093/67
Identifier Type: -
Identifier Source: org_study_id
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