Nutrition. 2024 Jun:122:112397. doi: 10.1016/j.nut.2024.112397.Epub 2024 Feb 15.

Giovanni Di Nardo ¹, Luca Bernardo ², Cesare Cremon ³, Giovanni Barbara ³, Enrico Felici ⁴, Melania Evangelisti ¹, Alessandro Ferretti ¹, Silvia Furio ¹, Marisa Piccirillo ¹, Flaminia Coluzzi ⁵, Pasquale Parisi ¹, Angela Mauro ², Clelia Di Mari ², Francesco D'Angelo ⁶, Maurizio Mennini ⁷

Author information

¹Sapienza University of Rome, NESMOS Department, Pediatric Unit, Sant'Andrea University Hospital, Rome, Italy.

²Pediatric Unit, Department of Childhood and Developmental Medicine, Fatebenefratelli-Sacco Hospital, Milan, Italy.

³Department of Medical and Surgical Sciences, University of Bologna and IRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy.

⁴Pediatric and Pediatric Emergency Unit, "Umberto Bosio" Center for Digestive Diseases, The Children Hospital, AO SS Antonio e Biagio e C. Arrigo, Alessandria, Italy.

⁵Sapienza University of Rome, Department of Medical and Surgical Sciences and Biotechnologies, Polo Pontino, Latina, Italy; Unit of Anaesthesia, Intensive Care and Pain Medicine, Sant'Andrea University Hospital, Rome, Italy.

⁶Sapienza University of Rome, NESMOS Department, General Surgery Unit, Sant'Andrea University Hospital, Rome, Italy.

⁷Sapienza University of Rome, NESMOS Department, Pediatric Unit, Sant'Andrea University Hospital, Rome, Italy. Electronic address: maurizio.mennini@gmail.com.

Abstract

Objective: This 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).

Methods: This 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.

Results: The 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.

Conclusions: Co-micronized PEA/PD is a safe and effective treatment to treat abdominal pain symptoms in pediatric IBS.