Evidence map›Paper›PMID 33274370›Full record

Trial reportThe Journal of nutrition2021

Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis.

David Schnadower, Robert E Sapien, T Charles Casper, Cheryl Vance, Phillip I Tarr, Karen J O'Connell, Adam C Levine, Cindy G Roskind, Alexander J Rogers, Seema R Bhatt and 7 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of nutrition, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01773967 (Impact of Emergency Department Probiotic), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 36% of its field
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.

NCT01773967 phase2 / phase3completednot on this map

Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis

TypeinterventionalSponsorWashington University School of MedicineRan2014 to 2018Enrolled971ConditionsGastroenteritisArmsLGG, micro-crystalline cellulose
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. 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

17 authors at 12 institutions in 2 countries.

David SchnadowerDivision of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Robert E SapienDepartment of Emergency Medicine, University of New Mexico, Albuquerque, NM, USA.
T Charles CasperDepartment of Pediatrics, University of Utah, Salt Lake City, UT, USA.
Cheryl VanceDepartments of Emergency Medicine and Pediatrics, University of California, Davis, School of Medicine, Sacramento, CA, USA.
Phillip I TarrDivision of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.
Karen J O'ConnellDivision of Emergency Medicine, Children's National Health System, Department of Pediatrics and Emergency Medicine, The George Washington School of Medicine and Health Sciences, Washington, DC, USA.
Adam C LevineDepartment of Emergency Medicine, Rhode Island Hospital/Hasbro Children's Hospital and Brown University, Providence, RI, USA.
Cindy G RoskindDivision of Emergency Medicine, Department of Pediatrics, Columbia University College of Physicians & Surgeons, New York, NY, USA.
Alexander J RogersDepartments of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor, MI, USA.
Seema R BhattDivision of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Prashant MahajanDepartments of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor, MI, USA.
Elizabeth C PowellDivision of Emergency Medicine, Department of Pediatrics, Ann & Robert H Lurie Children's Hospital, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Cody S OlsenDepartment of Pediatrics, University of Utah, Salt Lake City, UT, USA.
Marc H GorelickCentral Administration, Children's Minnesota, Minneapolis, MN, USA.
J Michael DeanDepartment of Pediatrics, University of Utah, Salt Lake City, UT, USA.
Stephen B FreedmanSections of Pediatric Emergency Medicine and Gastroenterology, Department of Pediatrics, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Pediatric Emergency Care Applied Research Network (PECARN) Probiotics Study
University of Utah · USCincinnati Children's Hospital Medical Center · USUniversity of Michigan · USBrown University · USChildren's Minnesota · USChildren's National · USColumbia University · USNorthwestern University · USUniversity of Calgary · CAUniversity of California, Davis · USUniversity of New Mexico · USWashington University in St. Louis · US

Funding

Washington University DDRCC Supplemental Equipment RequestP30DK052574 · NIDDK · WASHINGTON UNIVERSITY · PI Nicholas O. Davidson · 2000 to 2026
$30.8M
Impact of Emergency Department Probiotic Treatment of Pediatric GastroenteritisR01HD071915 · NICHD · WASHINGTON UNIVERSITY · PI FREEDMAN, STEPHEN BRADLEY, SCHNADOWER, DAVID · 2014 to 2018
$3.6M
NICHD NIH HHS R01 HD071915NIDDK NIH HHS P30 DK052574
6 · The paper itself

Abstract

backgroundGastroenteritis is a common and impactful disease in childhood. Probiotics are often used to treat acute gastroenteritis (AGE); however, in a large multicenter randomized controlled trial (RCT) in 971 children, Lactobacillus rhamnosus GG (LGG) was no better than placebo in improving patient outcomes.

objectivesWe sought to determine whether the effect of LGG is associated with age, weight z score and weight percentile adjusted for age and sex, or dose per kilogram administered.

methodsThis was a preplanned secondary analysis of a multicenter double-blind RCT of LGG 1 × 1010 CFU twice daily for 5 d or placebo in children 3-48 mo of age with AGE. Our primary outcome was moderate to severe gastroenteritis. Secondary outcomes included diarrhea and vomiting frequency and duration, chronic diarrhea, and side effects. We used multivariable linear and nonlinear models testing for interaction effects to assess outcomes by age, weight z score and weight percentile adjusted for age and sex, and dose per kilogram of LGG received.

resultsA total of 813 children (84%) were included in the analysis; 413 received placebo and 400 LGG. Baseline characteristics were similar between treatment groups. There were no differential interaction effects across ranges of age (P-interaction = 0.32), adjusted weight z score (P-interaction = 0.43), adjusted weight percentile (P-interaction = 0.45), or dose per kilogram of LGG received (P-interaction = 0.28) for the primary outcome. Whereas we found a statistical association favoring placebo at the extremes of adjusted weight z scores for the number of vomiting episodes (P-interaction = 0.02) and vomiting duration (P-interaction = 0.0475), there were no statistically significant differences in other secondary outcome measures (all P-interactions > 0.05).

conclusionsLGG does not improve outcomes in children with AGE regardless of the age, adjusted weight z score, and adjusted weight percentile of participants, or the probiotic dose per kilogram received. These results further strengthen the conclusions of low risk of bias clinical trials which demonstrate that LGG provides no clinical benefit in children with AGE.This trial was registered at clinicaltrials.gov as NCT01773967.

Indexed as

Body WeightChild, PreschoolDouble-Blind MethodGastroenteritisHumansInfantProbioticsemergency medicinegastroenteritispediatricprobioticrandomized controlled trialsecondary analysis

Identifiers

PMID33274370
PMCPMC7779240
OpenAlexW3108180053

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.