Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357897
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-05
Brief Title:
The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation
Sponsor:
Chulalongkorn University
Organization:
Chulalongkorn University
Study Overview
Official Title:
Faculty of Medicine Chulalongkorn University
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 - 1 gkgday for a duration of 56 days
Children in group B will receive the standard PEG formula Forlax at a dose of 05 - 1 gkgday 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
Children in group A will receive PEG-Chula at a dose of 05 - 1 gkgday for a duration of 56 days
Children in group B will receive the standard PEG formula Forlax at a dose of 05 - 1 gkgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None