Efficacy and palatability of the developed polyethylene glycol-based formula for the treatment of children with functional constipation.

BACKGROUND

Excipients may improve the palatability of polyethylene glycol (PEG), the first-line treatment for childhood functional constipation (FC), leading to good compliance and improved treatment outcomes.

AIM: To compare the developed PEG-based formula (PEG-Chula) to the commercial formula for treating childhood FC.

METHODS

In this randomized controlled trial, we enrolled children aged < 18 years with FC diagnosed by the Rome IV criteria to receive PEG-Chula [four flavors: (1) Strawberry; (2) Lychee; (3) Apple; and (4) Lychee-rose] or Forlax (orange-grapefruit flavor) for eight weeks. The primary outcomes included changes in stool frequency and consistency measured by the Bristol Stool scale. The secondary outcomes were constipation-related symptom improvement, adverse events, and palatability measured by the facial hedonic scale.

RESULTS

Fifty-two children diagnosed with FC [median age: 4.21 (2.33, 7.88) years; 35 (67.31%) females] were enrolled. After the 8-week treatment, the mean weekly stool frequency increased in both groups, the mean change was 4.02 (95%CI: 3.09-4.95) in PEG-Chula and 3.78 (95%CI: 2.79-4.78) in commercial PEG compared to baseline (P < 0.001). The extent of stool consistency improvement did not differ significantly. The most preferred PEG-Chula flavor was rated more palatable than the commercial PEG. Treatment compliance correlated with medication palatability (r = 0.34, P = 0.013). No significant differences in adverse events were found.

CONCLUSION

Both PEG-based formulas are effective and safe for managing pediatric FC.