• Giovanni Di Nardo, Luca Bernardo, Cesare Cremon, Giovanni Barbara, Enrico Felici, Melania Evangelisti, Alessandro Ferretti, Silvia Furio, Marisa Piccirillo, Flaminia Coluzzi, Pasquale Parisi, Angela Mauro, Di MariCleliaCPediatric Unit, Department of Childhood and Developmental Medicine, Fatebenefratelli-Sacco Hospital, Milan, Italy., Francesco D'Angelo, and Maurizio Mennini.
• Sapienza University of Rome, NESMOS Department, Pediatric Unit, Sant'Andrea University Hospital, Rome, Italy.
• Nutrition. 2024 Jun 1; 122: 112397112397.

ObjectiveThis study aimed 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).MethodsThis was a multicenter trial conducted at three Italian pediatric gastroenterology centers, employing a double-blind, placebo-controlled, parallel-arm design. Participants were ages 10 to 17 y and 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-wk period. The study assessed baseline severity using the IBS-Severity Scoring System (IBS-SSS) at enrollment and after 4, 8, and 12 wk of treatment. Abdominal pain frequency was assessed on a scale from 1 to 7 d/wk, 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 wk of therapy.ResultsThe study involved 70 children with IBS. Of the participants, 34 received co-micronized PEA/PD, and 36 received a placebo. As compared with the placebo group, the co-micronized therapy group had significantly more patients achieving complete remission after 12 wk (P = 0.015), with particular benefit in the IBS-diarrhea subtype (P = 0.01). The treatment group also experienced a significant reduction in abdominal pain intensity and frequency compared with the placebo group. No adverse events were recorded during the study period.ConclusionsCo-micronized PEA/PD is a safe and effective treatment to treat abdominal pain symptoms in pediatric IBS.Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.

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