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

NCT01773967 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 971

Last updated 2019-09-06

Study results available
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Summary

The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.

Conditions

Interventions

DRUG

LGG

LGG 10\^10 cfu PO BID X 5 days

DRUG

micro-crystalline cellulose

1 capsule PO bid x 5 days

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER
  • Northwestern University

    collaborator OTHER
  • University of New Mexico

    collaborator OTHER
  • Children's National Research Institute

    collaborator OTHER
  • University of Utah

    collaborator OTHER
  • Wayne State University

    collaborator OTHER
  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER
  • University of Michigan

    collaborator OTHER
  • Brown University

    collaborator OTHER
  • University of California, Davis

    collaborator OTHER
  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Kimberly Quayle, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01773967 on ClinicalTrials.gov