Effect of Limosilactobacillus reuteri DSM17938 to prevent antibiotic-associated diarrhea in children: prospective, multi-center, randomized, placebo-controlled clinical trial (PEARL Study)

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dc.authorid0000-0001-7624-3410
dc.contributor.authorDinleyici, Ener Çağrı
dc.contributor.authorÖzen, Metehan
dc.contributor.authorGüven, Şirin
dc.contributor.authorDalgıç, Nazan
dc.contributor.authorKarbuz, Adem
dc.contributor.authorSütçü, Murat
dc.contributor.authorYazar, Ahmet Sami
dc.contributor.authorid243394
dc.date.accessioned2025-06-27T14:08:29Z
dc.date.available2025-06-27T14:08:29Z
dc.date.issued2025-06
dc.departmentFakülteler, Sağlık Bilimleri Fakültesi, Çocuk Gelişimi Bölümü
dc.descriptionScience Citation Index Expanded (SCI-EXPANDED)
dc.description.abstractAntibiotic-associated diarrhea (AAD) is one of the side effects that occur during and after antibiotic use. Some probiotics have strain-specific beneficial effects on AAD development when used in combination with antibiotics. The aim of this study was to evaluate the effect of Limosilactobacillus reuteri DSM 17938 on the prevention of AAD in children. This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial in T & uuml;rkiye between 2017-2019, among outpatient children with acute otitis media (AOM) or acute rhinosinusitis (ARS). Group 1 (n = 330) received amoxicillin-clavulanate and L. reuteri DSM 17938 (2 x 10(8) CFU) and Group 2 (n = 324) received amoxicillin-clavulanate and a placebo during the antibiotic treatment or continued for 21 days after antibiotic cessation. The primary end point of this study was the percentage of children with AAD in the first 14, 21, and 56 days of follow-up. Secondary endpoints are the percentage of children with AAD regarding the AOM vs ARS, amoxicillin-clavulanate dose, age groups, and the comparison between 14- and 21-days use of L. reuteri. The percentage of children with AAD was significantly lower in the L. reuteri group compared to the placebo group at 14 days (7.9% vs. 16.7%; RR: 0.47, 95%CI 0.30-0.7; p < 0.001); at 21 days (8.8% vs. 17.9%; RR: 0.49, 95%CI 0.32-0.74;p < 0.001); and at 56 days (9.1% vs. 19.6%; RR: 0.46, 95%CI 0.30-0.69;p < 0.001). The incidence of AAD was also significantly lower in the L. reuteri group at 14, 21 and 56 days among children aged between 6-24 months (p < 0.01, p < 0.01, p < 0.001) or children with AOM (p = 0.0001,p < 0.0001,p < 0.0001). When AAD was observed, the mean duration of diarrhea was longer in the placebo group(p < 0.05). Conclusions: This first study with L. reuteri DSM 17938 in a large pediatric outpatient setting showed significant reduction of AAD during the first 14 days of antibiotic use and the 8-week follow-up period. Trial Registration: NCT02765217 (First Submitted 02.05.2016) (https://clinicaltrials.gov/study/NCT02765217?term=NCT02765217&rank=1).
dc.identifier.citationDinleyici, E.C., Özen, M., Güven, Ş., Dalgıç, N., Karbuz, A., ... Yazar, A.S. (2025). Effect of Limosilactobacillus reuteri DSM17938 to prevent antibiotic-associated diarrhea in children: prospective, multi-center, randomized, placebo-controlled clinical trial (PEARL Study). European Journal of Pediatrics, 184, 1-10. https://doi.org/10.1007/s00431-025-06249-8
dc.identifier.doi10.1007/s00431-025-06249-8
dc.identifier.eissn1432-1076
dc.identifier.endpage10
dc.identifier.issn0340-6199
dc.identifier.startpage1
dc.identifier.urihttps://dspace.mudanya.edu.tr/handle/20.500.14362/331
dc.identifier.volume184
dc.identifier.wosWOS:001505089700003
dc.identifier.wosqualityQ1
dc.institutionauthorYazar, Ahmet Sami
dc.language.isoen
dc.publisherSpringer
dc.relation.journalEuropean Journal of Pediatrics
dc.relation.publicationcategoryMakale- Uluslararası- Hakemli Dergi- Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectAntibiotic
dc.subjectAntibiotic associated diarrhea
dc.subjectProbiotic
dc.subjectLimosilactobacillus reuteri
dc.subjectL reuteri DSM 17938
dc.titleEffect of Limosilactobacillus reuteri DSM17938 to prevent antibiotic-associated diarrhea in children: prospective, multi-center, randomized, placebo-controlled clinical trial (PEARL Study)
dc.typeMakale
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