NCT06357897 The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation
| NCT ID | NCT06357897 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chulalongkorn University |
| Condition | Functional Constipation |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-05-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2024-05-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion 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.
Contact & Investigator
Palittiya Sintusek, Ph.D.
STUDY CHAIR
Chulalongkorn University
Frequently Asked Questions
Who can join the NCT06357897 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 18 Years, studying Functional Constipation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06357897 currently recruiting?
Yes, NCT06357897 is actively recruiting participants. Contact the research team at tdlong@ctump.edu.vn for enrollment information.
Where is the NCT06357897 trial being conducted?
This trial is being conducted at Bangkok, Thailand.
Who is sponsoring the NCT06357897 clinical trial?
NCT06357897 is sponsored by Chulalongkorn University. The principal investigator is Palittiya Sintusek, Ph.D. at Chulalongkorn University. The trial plans to enroll 52 participants.