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.
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
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 group | Role | What they receive |
|---|---|---|
| LGG | Experimental | LGG 10^10 cfu PO bid x 5 days Receives: Drug: LGG |
| Placebo | Placebo comparator | micro-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.
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)
Number of Participants With LGG Bacteremia
bacteremia caused by LGG
Measured: 1 month
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.
- First posted23 Jan 2013 (estimated)
- Study startJul 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Northwestern University, University of New Mexico, Children's National Research Institute, University of Utah, Wayne State University, Children's Hospital Medical Center, Cincinnati, University of Michigan, Brown University, University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Kimberly Quayle, MD, Principal investigator, Washington University School of Medicine
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 34596225Schnadower 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 34183579Freedman 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 34016656Poonai 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 33871616Schnadower 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 33274370Schnadower 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 30462938Schnadower 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 28947466Freedman 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
- ClinicalTrials.gov ID
- NCT01773967
- Acronym / sponsor ID
- 1R01HD071915
- Conditions
- Gastroenteritis
- Keywords
- Lactobacillus rhamnosus GG, LGG, Probiotic, Gastroenteritis, acute gastroenteritis, child, pediatric, RCT
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 971 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Columbia University, Northwestern University, University of New Mexico, Children's National Research Institute, University of Utah, Wayne State University, Children's Hospital Medical Center, Cincinnati, University of Michigan, Brown University, University of California, Davis
- Study start
- Jul 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.
Detailed description
Multicenter randomized controlled trial of LGG in patients 3-48 months of age presenting to the Emergency Department with acute gastroenteritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGG | Experimental | Drug: LGGLGG 10^10 cfu PO bid x 5 days |
| Placebo | Placebo comparator | Drug: micro-crystalline cellulosemicro-crystalline cellulose PO bid x 5 days |
Who may qualify
- Ages
- 3 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LGGAlso: Lactobacillus GG ATCC 53103, Lactobacillus rhamnosus, culturelleLGG 10^10 cfu PO BID X 5 days | Drug | LGG |
| micro-crystalline celluloseAlso: placebo micro-crystalline cellulose1 capsule PO bid x 5 days | Drug | Placebo |
Primary outcome
Number of Participants With Modified Vesikari Scale Score >=9
Time frame: 14 days
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.
2 secondary outcomes
Number of Participants With LGG Bacteremia
Time frame: 1 month
Diarrhea Duration
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34596225Freedman 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.
- Derived from this study: PubMed 34183579Schnadower 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.
- Derived from this study: PubMed 34016656Freedman 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.
- Derived from this study: PubMed 33871616Poonai 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.
- Derived from this study: PubMed 33274370Schnadower 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.
- Derived from this study: PubMed 30462938Schnadower 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.
- Derived from this study: PubMed 28947466Schnadower 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.
- Derived from this study: PubMed 24885220Freedman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Quayle, MD principal investigator
Washington University School of Medicine
10 sites in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.