Clinical trial NCT06357897: The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation
Official title: Faculty of Medicine, Chulalongkorn University
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Constipation
Keywords: Functional constipation
Children
Polyethylene glycol
Palatability
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group received PEG-Chula Control group received Forlax
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The frequency of stool
timeFrame: At 7 days, 14 days, 28 days and 56 days
measure: Stool consistency assessed by Bristol stool chart
timeFrame: At 7 days, 14 days, 28 days and 56 days
Secondary outcomes:
measure: Fecal incontinence
timeFrame: At 7 days, 14 days, 28 days and 56 days
measure: Rectal diameter
timeFrame: At 7 days, 14 days, 28 days and 56 days
measure: Adverse events
timeFrame: At 7 days, 14 days, 28 days and 56 days
measure: Palatability of medication assessed by facial Hedonic scale
timeFrame: At 7 days, 14 days, 28 days and 56 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Palittiya Sintusek, Ph.D.
role: STUDY_CHAIR
References: