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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Gastroenteritis

In brief

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

Key facts

Study ID

NCT01773967

Run by

Washington University School of Medicine

People needed

971

Starts

2014-07-01

Expected to finish

2018-08-01

Last updated by the study team

2019-09-06

Who can join

Age: 0 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• UC Davis Medical Center — Sacramento, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Lurie Children's Hospital — Chicago, Illinois, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Children's Hospital of New York — New York, New York, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Hasbro Children's Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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