NCT01773967

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
971

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2014

Typical duration for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 6, 2019

Completed
Last Updated

September 6, 2019

Status Verified

August 1, 2019

Enrollment Period

4.1 years

First QC Date

January 10, 2013

Results QC Date

June 25, 2019

Last Update Submit

August 13, 2019

Conditions

Gastroenteritis

Keywords

Lactobacillus rhamnosus GGLGGProbioticGastroenteritisacute gastroenteritischildpediatricRCT

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Modified Vesikari Scale Score >=9

    This is a validated gastroenteritis severity score that includes duration and frequency of diarrhea, duration and frequency of vomiting, duration and frequency of fever and use of health care resources. Scores \>=9 indicate moderate-severe gastroenteritis. Higher is worse.

    14 days

Secondary Outcomes (2)

  • Number of Participants With LGG Bacteremia

    1 month

  • Diarrhea Duration

    14 days

Study Arms (2)

LGG

EXPERIMENTAL

LGG 10\^10 cfu PO bid x 5 days

Drug: LGG

Placebo

PLACEBO COMPARATOR

micro-crystalline cellulose PO bid x 5 days

Drug: micro-crystalline cellulose

Interventions

LGGDRUG

LGG 10\^10 cfu PO BID X 5 days

Also known as: Lactobacillus GG ATCC 53103, Lactobacillus rhamnosus, culturelle
LGG
micro-crystalline celluloseDRUG

1 capsule PO bid x 5 days

Also known as: placebo micro-crystalline cellulose
Placebo

Eligibility Criteria

Age3 Months - 48 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 3-48 months (have not yet reached their fourth birthday); AND
  • Presence of 3 or more watery stools within 24 hours of screening; AND
  • Duration of vomiting or diarrhea less than 7 days; AND
  • Symptoms consistent with acute intestinal infectious process.

You may not qualify if:

  • Presence of an indwelling vascular access line; OR
  • Presence of structural heart disease excluding non-pathological heart murmurs; OR
  • Receiving immunosuppressive therapy or history of immunodeficiency; OR
  • Hematochezia in the preceding 48 hours; OR
  • Chronic gastrointestinal problems (e.g. short gut syndrome, inflammatory bowel disease); OR
  • Patients with known pancreatitis; OR
  • History of abdominal surgery; OR
  • Critically ill patients; OR
  • Family member with an indwelling vascular access line, or on immunosuppressive therapy, or with a known immunodeficiency; OR
  • Bilious emesis; OR
  • Probiotic use (supplement) in the preceding 2 weeks; OR
  • Oral or intravenous steroid use in the preceding six months; OR
  • Previously enrolled in this trial; OR
  • Allergy to lactobacillus or Microcrystalline Cellulose (MCC); OR
  • Allergy to erythromycin, clindamycin, AND betalactam antibiotics (all); OR
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Children's Hospital of New York

New York, New York, 10032, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (8)

  • Freedman SB, Finkelstein Y, Pang XL, Chui L, Tarr PI, VanBuren JM, Olsen C, Lee BE, Hall-Moore CA, Sapien R, O'Connell K, Levine AC, Poonai N, Roskind C, Schuh S, Rogers A, Bhatt S, Gouin S, Mahajan P, Vance C, Hurley K, Powell EC, Farion KJ, Schnadower D. Pathogen-Specific Effects of Probiotics in Children With Acute Gastroenteritis Seeking Emergency Care: A Randomized Trial. Clin Infect Dis. 2022 Aug 24;75(1):55-64. doi: 10.1093/cid/ciab876.

    PMID: 34596225DERIVED

  • Schnadower D, O'Connell KJ, VanBuren JM, Vance C, Tarr PI, Schuh S, Hurley K, Rogers AJ, Poonai N, Roskind CG, Bhatt SR, Gouin S, Mahajan P, Olsen CS, Powell EC, Farion K, Sapien RE, Chun TH, Freedman SB; Pediatric Emergency Care Applied Research Network and Pediatric Emergency Research Canada. Association Between Diarrhea Duration and Severity and Probiotic Efficacy in Children With Acute Gastroenteritis. Am J Gastroenterol. 2021 Jul 1;116(7):1523-1532. doi: 10.14309/ajg.0000000000001295.

    PMID: 34183579DERIVED

  • Freedman SB, Roskind CG, Schuh S, VanBuren JM, Norris JG, Tarr PI, Hurley K, Levine AC, Rogers A, Bhatt S, Gouin S, Mahajan P, Vance C, Powell EC, Farion KJ, Sapien R, O'Connell K, Poonai N, Schnadower D; Pediatric Emergency Research Canada and Pediatric Emergency Care Applied Research Networks. Comparing Pediatric Gastroenteritis Emergency Department Care in Canada and the United States. Pediatrics. 2021 Jun;147(6):e2020030890. doi: 10.1542/peds.2020-030890. Epub 2021 May 20.

    PMID: 34016656DERIVED

  • Poonai N, Powell EC, Schnadower D, Casper TC, Roskind CG, Olsen CS, Tarr PI, Mahajan P, Rogers AJ, Schuh S, Hurley KF, Gouin S, Vance C, Farion KJ, Sapien RE, O'Connell KJ, Levine AC, Bhatt S, Freedman SB; Pediatric Emergency Care Applied Research Network (PECARN) and Pediatric Emergency Research Canada (PERC). Variables Associated With Intravenous Rehydration and Hospitalization in Children With Acute Gastroenteritis: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2021 Apr 1;4(4):e216433. doi: 10.1001/jamanetworkopen.2021.6433.

    PMID: 33871616DERIVED

  • Schnadower D, Sapien RE, Casper TC, Vance C, Tarr PI, O'Connell KJ, Levine AC, Roskind CG, Rogers AJ, Bhatt SR, Mahajan P, Powell EC, Olsen CS, Gorelick MH, Dean JM, Freedman SB; Pediatric Emergency Care Applied Research Network (PECARN) Probiotics Study. Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis. J Nutr. 2021 Jan 4;151(1):65-72. doi: 10.1093/jn/nxaa313.

    PMID: 33274370DERIVED

  • Schnadower D, Tarr PI, Casper TC, Gorelick MH, Dean JM, O'Connell KJ, Mahajan P, Levine AC, Bhatt SR, Roskind CG, Powell EC, Rogers AJ, Vance C, Sapien RE, Olsen CS, Metheney M, Dickey VP, Hall-Moore C, Freedman SB. Lactobacillus rhamnosus GG versus Placebo for Acute Gastroenteritis in Children. N Engl J Med. 2018 Nov 22;379(21):2002-2014. doi: 10.1056/NEJMoa1802598.

    PMID: 30462938DERIVED

  • Schnadower D, Tarr PI, Casper TC, Gorelick MH, Dean MJ, O'Connell KJ, Mahajan P, Chun TH, Bhatt SR, Roskind CG, Powell EC, Rogers AJ, Vance C, Sapien RE, Gao F, Freedman SB. Randomised controlled trial of Lactobacillus rhamnosus (LGG) versus placebo in children presenting to the emergency department with acute gastroenteritis: the PECARN probiotic study protocol. BMJ Open. 2017 Sep 24;7(9):e018115. doi: 10.1136/bmjopen-2017-018115.

    PMID: 28947466DERIVED

  • Freedman SB, Williamson-Urquhart S, Schuh S, Sherman PM, Farion KJ, Gouin S, Willan AR, Goeree R, Johnson DW, Black K, Schnadower D, Gorelick MH; Pediatric Emergency Research Canada (PERC) Gastroenteritis Study Group. Impact of emergency department probiotic treatment of pediatric gastroenteritis: study protocol for the PROGUT (Probiotic Regimen for Outpatient Gastroenteritis Utility of Treatment) randomized controlled trial. Trials. 2014 May 14;15:170. doi: 10.1186/1745-6215-15-170.

    PMID: 24885220DERIVED

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Dr. David Schnadower
Organization
Cincinnati Children's Hospital Medical Center
david.schnadower@cchmc.org
5138035526

Study Officials

  • Kimberly Quayle, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 23, 2013

Study Start

July 1, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

September 6, 2019

Results First Posted

September 6, 2019

Record last verified: 2019-08

Locations

US(10)