Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
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ClinicalTrials.gov Identifier: NCT01773967 |
Recruitment Status :
Completed
First Posted : January 23, 2013
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroenteritis | Drug: LGG Drug: micro-crystalline cellulose | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 971 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis |
Actual Study Start Date : | July 2014 |
Actual Primary Completion Date : | August 2018 |
Actual Study Completion Date : | August 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: LGG
LGG 10^10 cfu PO bid x 5 days
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Drug: LGG
LGG 10^10 cfu PO BID X 5 days
Other Names:
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Placebo Comparator: Placebo
micro-crystalline cellulose PO bid x 5 days
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Drug: micro-crystalline cellulose
1 capsule PO bid x 5 days
Other Name: placebo micro-crystalline cellulose |
- 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.
- Number of Participants With LGG Bacteremia [ Time Frame: 1 month ]bacteremia caused by LGG
- Diarrhea Duration [ Time Frame: 14 days ]diarrhea duration in hours after randomization

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Ages Eligible for Study: | 3 Months to 48 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773967
United States, California | |
UC Davis Medical Center | |
Sacramento, California, United States, 95817 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010 | |
United States, Illinois | |
Lurie Children's Hospital | |
Chicago, Illinois, United States, 60611 | |
United States, Michigan | |
University of Michigan Health System | |
Ann Arbor, Michigan, United States, 48109 | |
Children's Hospital of Michigan | |
Detroit, Michigan, United States, 48201 | |
United States, Missouri | |
St. Louis Children's Hospital | |
Saint Louis, Missouri, United States, 63110 | |
United States, New Mexico | |
University of New Mexico | |
Albuquerque, New Mexico, United States, 87106 | |
United States, New York | |
Children's Hospital of New York | |
New York, New York, United States, 10032 | |
United States, Ohio | |
Cincinnati Children's Hospital | |
Cincinnati, Ohio, United States, 45229 | |
United States, Rhode Island | |
Hasbro Children's Hospital | |
Providence, Rhode Island, United States, 02903 |
Principal Investigator: | Kimberly Quayle, MD | Washington University School of Medicine |
Documents provided by Washington University School of Medicine:
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT01773967 |
Obsolete Identifiers: | NCT00970164 |
Other Study ID Numbers: |
1R01HD071915 ( U.S. NIH Grant/Contract ) |
First Posted: | January 23, 2013 Key Record Dates |
Results First Posted: | September 6, 2019 |
Last Update Posted: | September 6, 2019 |
Last Verified: | August 2019 |
Lactobacillus rhamnosus GG LGG Probiotic Gastroenteritis |
acute gastroenteritis child pediatric RCT |
Gastroenteritis Emergencies Disease Attributes |
Pathologic Processes Gastrointestinal Diseases Digestive System Diseases |