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GastroenteritisPhase 2/3NCT01773967

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

A Phase 2/3 study testing LGG and micro-crystalline cellulose in people with Gastroenteritis, run by Washington University School of Medicine at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 3 to 48 months
Conditions the study is for
Gastroenteritis
What is being tested?
LGG and micro-crystalline cellulose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
971 participants
Where
10 sitesUnited States
Study dates
Jul 2014to Aug 2018
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 48 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • Not available for daily follow-up while symptomatic; OR
  • Parent/guardian not speaking English or Spanish; OR
  • Under 6 months old AND premature (<37 weeks).

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87106

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Lurie Children's Hospital

    Chicago, Illinois, 60611

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Children's Hospital of New York

    New York, New York, 10032

  • Hasbro Children's Hospital

    Providence, Rhode Island, 02903

  • UC Davis Medical Center

    Sacramento, California, 95817

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

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

Read the detailed description

Multicenter randomized controlled trial of LGG in patients 3-48 months of age presenting to the Emergency Department with acute gastroenteritis.

Conditions
Gastroenteritis
Being tested
LGG, micro-crystalline cellulose
Keywords
Lactobacillus rhamnosus GG, LGG, Probiotic, Gastroenteritis, acute gastroenteritis, child, pediatric, RCT
Medical subject headings
Gastroenteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LGGDrug

    Also called Lactobacillus GG ATCC 53103, Lactobacillus rhamnosus, culturelle

    LGG 10^10 cfu PO BID X 5 days

  • micro-crystalline celluloseDrug

    Also called placebo micro-crystalline cellulose

    1 capsule PO bid x 5 days

Study groups in NCT01773967
Study groupRoleWhat they receive
LGGExperimentalLGG 10^10 cfu PO bid x 5 days
Receives: Drug: LGG
PlaceboPlacebo comparatormicro-crystalline cellulose PO bid x 5 days
Receives: Drug: micro-crystalline cellulose

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 14 days

Secondary outcomes (2)

  1. Number of Participants With LGG Bacteremia

    bacteremia caused by LGG

    Measured: 1 month

  2. Diarrhea Duration

    diarrhea duration in hours after randomization

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2013 (estimated)
  2. Study startJul 2014
  3. Primary completionAug 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
971 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01773967
Sponsor's protocol ID
1R01HD071915
Status last verified
Aug 2019
First submitted
10 Jan 2013
Last updated
6 Sep 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34596225

  • 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.

    PubMed 34183579

  • 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.

    PubMed 34016656

  • 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.

    PubMed 33871616

  • 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.

    PubMed 33274370

  • 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.

    PubMed 30462938

  • 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.

    PubMed 28947466

  • 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.

    PubMed 24885220

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing LGG and micro-crystalline cellulose in people with Gastroenteritis, run by Washington University School of Medicine at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Modified Vesikari Scale Score >=9 (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01773967, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.

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