Evidence map›Paper›PMID 40488914›Full record

Trial reportEuropean journal of pediatrics2025

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

Ener Cagri Dinleyici, Metehan Ozen, Sirin Guven, Nazan Dalgic, Adem Karbuz, Murat Sutcu, Ozden Turel, Fatma Nur Oz, Ulviye Kirli, Sevgi Yasar Durmus and 4 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in European journal of pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02765217 (Effect of Lactobacillus Reuteri DSM 17938 to Prevent Antibiotic-associated Diarrhea in Children), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02765217 phase4completednot on this map

Effect of Lactobacillus Reuteri DSM 17938 to Prevent Antibiotic-associated Diarrhea in Children: Prospective, Multi-center, Randomize, Parallel Group Placebo Controlled Clinical Trial

TypeinterventionalSponsorEskisehir Osmangazi UniversityRan2017 to 2020Enrolled1,325ConditionsAntibiotic Associated DiarrheaArmsLactobacillus reuteri DSM 17938, Placebo, Amoxicillin-Clavulanic Acid
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Ener Cagri DinleyiciDepartment of Pediatrics, Faculty of Medicine, Eskisehir Osmangazi University, Eskisehir, TR-26040, Türkiye. timboothtr@yahoo.com.ORCID http://orcid.org/0000-0002-0339-0134
Metehan OzenPediatric Infectious Disease Unit, Acıbadem University School of Medicine, Istanbul, Türkiye.
Sirin GuvenDepartment of Pediatrics, Prof. Dr. Ilhan Varank Training and Research Hospital, Istanbul, Türkiye.
Nazan DalgicPediatric Infectious Disease Unit, Health Sciences University Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Türkiye.
Adem KarbuzPediatric Infectious Disease Unit, Dr. Cemil Tascioglu City Hospital, Istanbul, Türkiye.
Murat SutcuPediatric Infectious Disease Unit, Istinye University Faculty of Medicine, Istanbul, Türkiye.
Ozden TurelPediatric Infectious Disease Unit, Istanbul Medeniyet University, Goztepe Education and Training Hospital, Prof Dr Suleyman Yalcin City Hospital, Istanbul, Türkiye.
Fatma Nur OzPediatric Infectious Disease Unit, Health Science University, Etlik City Hospital, Ankara, Türkiye.
Ulviye KirliDepartment of Pediatrics, Muğla Sıtkı Koçman University School of Medicine, Mugla, Türkiye.
Sevgi Yasar DurmusPediatric Infectious Disease Unit, Kayseri City Hospital, Kayseri, Türkiye.
Ahmet Sami YazarDepartment of Pediatrics, VM Medical Park Hospital, Istanbul, Türkiye.
Zeynep Ebru CakinDepartment of Pediatrics, Bagcilar Research and Training Hospital, Istanbul, Türkiye.
Yvan VandenplasKidZ Health Castle, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
Ates KaraPediatric Infectious Disease Unit, Hacettepe University Faculty of Medicine, Ankara, Türkiye.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Antibiotic-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 Türkiye 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 × 10

conclusionsThis 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 registrationNCT02765217 (First Submitted 02.05.2016) ( https://clinicaltrials.gov/study/NCT02765217?term=NCT02765217&rank=1 ). WHAT IS KNOWN: • Antibiotic associated diarrhea (AAD) is one of the common complications of antibiotic use in children and selected probiotics may have a strain-specific effect to prevent AAD • There are limited studies about the effects of Limosilactobacillus reuteri DSM 17938 on AAD, and no study available in pediatric outpatient setting. WHAT IS NEW: • Limosilactobacillus reuteri DSM 17938 significantly reduced the incidence of AAD in children at 14-, 21-, and 56- days follow-up. • The effect is mainly observed in children aged between 6 and 24 months or children with AOM.

Indexed as

Anti-Bacterial AgentsDiarrheaLimosilactobacillus reuteriProbioticsAmoxicillin-Potassium Clavulanate CombinationChildChild, PreschoolDouble-Blind MethodFemaleHumansInfantMaleOtitis MediaProspective StudiesSinusitisTreatment OutcomeAmoxicillin-Potassium Clavulanate CombinationAnti-Bacterial AgentsAntibioticAntibiotic associated diarrheaLimosilactobacillus reuteriL reuteri DSM 17938Probiotic

Identifiers

PMID40488914
PMCPMC12149013

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.