Evidence map›Paper›PMID 30531312›Full record

Trial reportThe Pediatric infectious disease journal2019

Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age.

Margaret N Kosek, Pablo Peñataro-Yori, Maribel Paredes-Olortegui, John Lefante, Cesar Ramal-Asayag, Marcelo Zamora-Babilonia, Graciela Meza-Sanchez, Richard A Oberhelman

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The Pediatric infectious disease journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Efficacy and Safety ofNutrients · 2026
    Pooled it
  2. Probiotics for preventing acute upper respiratory tract infections.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Safety ofNutrients · 2026
    Trial
  4. Article
  5. Article
  6. Review
  7. The Impact ofMicroorganisms · 2024
    Review
  8. Review
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

8 authors.

Margaret N KosekFrom the Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Pablo Peñataro-YoriAsociación Benéfica Prisma, Unidad de Investigaciones Biomédicas, Iquitos, Peru.
Maribel Paredes-OlorteguiAsociación Benéfica Prisma, Unidad de Investigaciones Biomédicas, Iquitos, Peru.
John LefanteTulane School of Public Health and Tropical Medicine, New Orleans, Louisiana.
Cesar Ramal-AsayagAsociación Benéfica Prisma, Unidad de Investigaciones Biomédicas, Iquitos, Peru.
Marcelo Zamora-BabiloniaAsociación Benéfica Prisma, Unidad de Investigaciones Biomédicas, Iquitos, Peru.
Graciela Meza-SanchezAsociación Benéfica Prisma, Unidad de Investigaciones Biomédicas, Iquitos, Peru.
Richard A OberhelmanTulane School of Public Health and Tropical Medicine, New Orleans, Louisiana.

Funding

Enabling Infectious Disease Research Capacity in the Peruvian AmazonD43TW010913 · FIC · UNIVERSITY OF VIRGINIA · PI Margaret N Kosek, MARIBEL PAREDES OLORTEGUI · 2018 to 2026
$2.8M
L. reuteri for Pediatric Diarrhea in Peru: Growth, Enteropathy, and MicrobiotaU01DK105849 · NIDDK · UNIVERSITY OF VIRGINIA · PI KOSEK, MARGARET N, OBERHELMAN, RICHARD A · 2014 to 2019
$2.0M
Probiotics in Pediatric Diarrhea in Peru_SupplementU01AT002733 · NCCIH · TULANE UNIVERSITY OF LOUISIANA · PI OBERHELMAN, RICHARD A · 2009 to 2012
$1.6M
FIC NIH HHS D43 TW010913NCCIH NIH HHS U01 AT002733NIDDK NIH HHS U01 DK105849
6 · The paper itself

Abstract

Probiotics are increasingly used for diarrhea, but studies under the Food and Drug Administration and Investigational New Drug program are few. We conducted a phase-one placebo-controlled study of Lactobacillus reuteri DSM 17938 under Investigational New Drug program in 60 children 2-5 years of age (41 L. reuteri, 19 placebos) in a resource-constrained community in Peru. No differences in objective data on adverse events were noted, although some differences based on subjective parental reports for fever and diarrhea were seen.

Indexed as

BiomarkersChild, PreschoolDiarrheaDrug Administration ScheduleFemaleHumansLimosilactobacillus reuteriMaleProbioticsSymptom AssessmentTreatment OutcomeBiomarkers

Identifiers

PMID30531312
PMCPMC6557701

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.