{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T19:04:16Z","timestamp":1788375856878,"version":"build-2803163510"},"reference-count":24,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,1,9]],"date-time":"2023-01-09T00:00:00Z","timestamp":1673222400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Paediatrics Child Health"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>Melatonin seems to have a positive impact on the brain\u2013gut axis and many direct and indirect effects on the gastrointestinal tract. This trial aimed at assessing the efficacy of melatonin combined with Lactobacillus Rhamnosus GG given in the treatment of paediatric patients with functional abdominal pain disorders.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Forty\u2010two patients aged 4\u201318\u2009years old who fulfilled the Rome IV Diagnostic Criteria for functional abdominal pain disorders were enrolled. Melatonin 3 or 5\u00a0mg in combination with Lactobacillus Rhamnosus GG (group 1, <jats:italic>n<\/jats:italic>\u00a0=\u200922) or a placebo in combination with Lactobacillus Rhamnosus GG (control group, <jats:italic>n<\/jats:italic>\u00a0=\u200920) were taken in the evening for a period of 4\u2009weeks. The study duration was 12\u2009weeks. The primary study endpoint was represented by clinical improvement at week 12 \u2013 defined as at least a 50% reduction in mean abdominal pain index (API) from baseline to week 12.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The mean API was reduced by more than 50% between T0 and T2 in the group of children treated with melatonin. However, the difference in the distributions of the variations of the scores between the two groups was not significant between T0 and T2 (<jats:italic>P<\/jats:italic>\u00a0=\u20090.082), while it was significant between T0 and T1 (<jats:italic>P<\/jats:italic>\u00a0=\u20090.001). Similar results were obtained by analysing the API variables \u2018weekly frequency of pain\u2019 (item 1) and \u2018perceived intensity of pain\u2019 (item 4) individually.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This is the first study to investigate the role of the combination of melatonin and Lactobacillus Rhamnosus GG in the treatment of children with functional abdominal pain disorders. Melatonin combined with Lactobacillus Rhamnosus GG can be considered a therapeutic option for these conditions in children.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jpc.16323","type":"journal-article","created":{"date-parts":[[2023,1,10]],"date-time":"2023-01-10T07:20:57Z","timestamp":1673335257000},"page":"458-463","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Randomised controlled trial of melatonin for paediatric functional abdominal pain disorders"],"prefix":"10.1111","volume":"59","author":[{"given":"Valeria","family":"Dipasquale","sequence":"first","affiliation":[{"name":"Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood \u201cG. 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