The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Local PEG4000, Commercial PEG4000.
- Who it may be relevant to
- Registry conditions: Functional Constipation. Basic parameters: 6 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Faculty of Medicine, Chulalongkorn University
Overview
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.
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- The frequency of stool [Time frame: At 7 days, 14 days, 28 days and 56 days]
- Stool consistency assessed by Bristol stool chart [Time frame: At 7 days, 14 days, 28 days and 56 days]
Secondary outcome measures (6)
- Fecal incontinence [Time frame: At 7 days, 14 days, 28 days and 56 days]
- Rectal diameter measured by transabdominal ultrasonography [Time frame: At 7 days, 14 days, 28 days, 56 days and 2 years]
- Anterior wall thickness measured by transabdominal ultrasonography [Time frame: At 7 days, 14 days, 28 days, 56 days and 2 years]
- Adverse events [Time frame: At 7 days, 14 days, 28 days and 56 days]
- Palatability of medication assessed by facial Hedonic scale [Time frame: At 7 days, 14 days, 28 days and 56 days]
- Change of gut microbiota before and after treatment [Time frame: At baseline and 56 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Faculty of Medicine, Chulalongkorn University — Bangkok
Identifiers
NCT: NCT06357897 · 0093/67