Phase 3
N=971
Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
Gastroenteritis
Bottom Line
View on ClinicalTrials.gov: NCT01773967 ↗Enrolled (actual)
971
Serious AEs
2.2%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants With Modified Vesikari Scale Score >=9 — 55; 60 Participants — p=0.83
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LGG (Drug); micro-crystalline cellulose (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Modified Vesikari Scale Score >=9 |
55; 60 | 0.83 |
| SECONDARY Number of Participants With LGG Bacteremia |
0; 0 | — |
| SECONDARY Diarrhea Duration |
49.7; 50.9 | 0.26 |
Summary
The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01773967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.