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



Status:Completed
Conditions:Hospital, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:Any
Updated:2/27/2019
Start Date:July 2014
End Date:August 2018

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

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

Inclusion Criteria:

1. Age 3-48 months (have not yet reached their fourth birthday); AND

2. Presence of 3 or more watery stools within 24 hours of screening; AND

3. Duration of vomiting or diarrhea less than 7 days; AND

4. Symptoms consistent with acute intestinal infectious process.

Exclusion Criteria:

1. Presence of an indwelling vascular access line; OR

2. Presence of structural heart disease excluding non-pathological heart murmurs; OR

3. Receiving immunosuppressive therapy or history of immunodeficiency; OR

4. Hematochezia in the preceding 48 hours; OR

5. Chronic gastrointestinal problems (e.g. short gut syndrome, inflammatory bowel
disease); OR

6. Patients with known pancreatitis; OR

7. History of abdominal surgery; OR

8. Critically ill patients; OR

9. Family member with an indwelling vascular access line, or on immunosuppressive
therapy, or with a known immunodeficiency; OR

10. Bilious emesis; OR

11. Probiotic use (supplement) in the preceding 2 weeks; OR

12. Oral or intravenous steroid use in the preceding six months; OR

13. Previously enrolled in this trial; OR

14. Allergy to lactobacillus or Microcrystalline Cellulose (MCC); OR

15. Allergy to erythromycin, clindamycin, AND betalactam antibiotics (all); OR

16. Not available for daily follow-up while symptomatic; OR

17. Parent/guardian not speaking English or Spanish; OR

18. Under 6 months old AND premature (<37 weeks).
We found this trial at
10
sites
New York, New York 10032
2435
mi
from 91732
New York, NY
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Sacramento, California 95814
366
mi
from 91732
Sacramento, CA
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
648
mi
from 91732
Albuquerque, NM
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
1932
mi
from 91732
Ann Arbor, MI
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Chicago, Illinois 60611
1729
mi
from 91732
Chicago, IL
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Cincinnati, Ohio 45229
1880
mi
from 91732
Cincinnati, OH
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
1966
mi
from 91732
Detroit, MI
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Providence, Rhode Island 02903
2562
mi
from 91732
Providence, RI
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Saint Louis, Missouri 63110
1569
mi
from 91732
Saint Louis, MO
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
2281
mi
from 91732
Washington,
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