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

The Washington University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Gastroenteritis

Treatments: Drug: LGG; Drug: micro-crystalline cellulose

Study type: Interventional

Funder types: Other

Identifiers

NCT01773967

1R01HD071915

Details and patient eligibility

About

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

Full description

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

Enrollment: 971 patients

Sex: All

Ages: 3 to 48 months old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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971 participants in 2 patient groups, including a placebo group

LGG

Experimental group

Description:

LGG 10\^10 cfu PO bid x 5 days

Treatment:

Drug: LGG

Placebo

Placebo Comparator group

Description:

micro-crystalline cellulose PO bid x 5 days

Treatment:

Drug: micro-crystalline cellulose