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

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Brown University; Children's Hospital Medical Center, Cincinnati; Children's National Research Institute; Children's Research Institute; Columbia University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Northwestern University; University of California, Davis; University of Michigan; University of New Mexico; University of Utah; Wayne State University

Criteria

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).