Palmitoylethanolamide and polydatin in pediatric irritable bowel syndrome: A multicentric randomized controlled trial

to evaluate the efficacy and safety of co-micronized palmitoylethanolamide (PEA)/polydatin (PD) in the treatment of abdominal pain symptoms in pediatric patients with Irritable Bowel Syndrome (IBS). The study was a multicenter trial conducted at three Italian pediatric gastroenterology centers, employing a double-blind, placebo-controlled, parallel-arm design. Participants, aged 10 to 17 years, met Rome IV criteria for pediatric IBS. They were randomly allocated to receive either co-micronized PEA/PD or placebo, administered three times daily in a 1:1 ratio, over a 12-week period. The study assessed baseline severity using the IBS-Severity Scoring System (IBS-SSS) at enrolment and after 4, 8, and 12 weeks of treatment. Assessment of abdominal pain frequency occurred on a scale from 1 to 7 days per week, while stool consistency was classified using the Bristol stool scale (BSS) to categorize various IBS subtypes. The primary outcome was the percentage of patients who achieved complete remission, defined as IBS-SSS score < 75 points after 12 weeks of therapy. The study involved 70 children with IBS, where 34 received co-micronized PEA/PD and 36 received a placebo. As compared with placebo group, the co-micronized therapy group had significantly more patients achieving complete remission after 12 weeks (p=0.015), with particular benefit in IBS-diarrhoea subtype (p=0.01). Treatment group also experienced a significant reduction in abdominal pain intensity and frequency compared to the placebo group. No adverse events were recorded during the study period. Co-micronized PEA/PD is a safe and effective treatment to treat abdominal pain symptoms in pediatric IBS.