Faculty of Medicine, Chulalongkorn University
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 18
Healthy Volunteers: t
View:
⁃ 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
Locations
Other Locations
Thailand
Faculty of Medicine, Chulalongkorn University
RECRUITING
Bangkok
Contact Information
Primary
Duc Long Tran, M.D.
tdlong@ctump.edu.vn
+66916668748
Time Frame
Start Date: 2024-05-03
Estimated Completion Date: 2026-12
Participants
Target number of participants: 52
Treatments
Experimental: 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.
Other: Standard PEG
Standard PEG (Forlax) is prepared into the sachets labelled A, B, C and D with similar packaging and appearance.
Related Therapeutic Areas
Sponsors
Leads: Chulalongkorn University