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

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

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

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

Conditions
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Gastroenteritis

Intervention / Treatment
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* Drug: LGG
* Drug: micro-crystalline cellulose


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LGG<br>LGG 10^10 cfu PO bid x 5 days | Drug: LGG<br>* LGG 10^10 cfu PO BID X 5 days<br>* Other names: culturelle;|
| Placebo Comparator: Placebo<br>micro-crystalline cellulose PO bid x 5 days | Drug: micro-crystalline cellulose<br>* 1 capsule PO bid x 5 days<br>* Other names: placebo micro-crystalline cellulose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With LGG Bacteremia | bacteremia caused by LGG | 1 month | 
| Diarrhea Duration | diarrhea duration in hours after randomization | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactobacillus rhamnosus GG, LGG, Probiotic, Gastroenteritis, acute gastroenteritis, child, pediatric, RCT