The efficacy and palatability of developed polyethylene glycol-based formula for children with functional constipation

Background: Polyethylene glycol (PEG) is the first-line treatment for childhood functional constipation (FC). Inactive ingredients like sweeteners and flavors may improve the palatability of PEG, leading to good compliance and favorable treatment outcomes. This study aimed to compare the efficacy, safety and palatability of a developed PEG-based formula (PEG-Chula) with the commercial formula available in Thailand for treating childhood FC.Method: This randomized controlled trial enrolled children aged 6 months to 18 years with FC diagnosed by the Rome IV criteria. Participants were randomly assigned (1:1) to receive PEG-Chula (four flavors: strawberry, lychee, green apple, lychee-rose) or Forlax (orange-grapefruit flavor) for 8 weeks. Primary outcomes included changes in stool frequency and consistency in the intervention period, while secondary outcomes included improvement of constipation-related symptoms, adverse events, and palatability. Stool consistency was assessed using the Bristol Stool Scale (score 1-7), and palatability was measured with the facial Hedonic Scale (score 1-5).Results: Fifty-two children diagnosed FC were randomly assigned to either the PEG-Chula group (n = 26) or commercial PEG group (n = 26). One child in the commercial PEG group was excluded due to missing efficacy data. The median age was 4.21 (2.33, 7.88) years, and 35 children (67.31%) were female. The stool frequency per week at baseline was 1.96 ± 0.58 in the PEG-Chula group and 2.21 ± 0.74 in the commercial PEG group (P = 0.18). After 8-week treatment, the mean stool frequency per week and stool consistency significantly increased in both groups. There were no statistical difference of stool frequency between 2 groups. The improvement of stool consistency was significantly different between the 2 groups only at week 2 (P = 0.045) and comparable at the end of treatment. The palatability of the most preferred flavor in 4 flavors of PEG-Chula was rated higher than commercial PEG. There was the correlation between overall compliance and the overall palatability (r = 0.34, P = 0.013). No significant differences were found in dosage or adverse events in 8-week period.Conclusion: Both PEG-based formulas are effective and safe for managing paediatric FC. Increasing palatability might improve patient’s compliance to medicine.