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

Phase 2

Completed

• Conditions: Gastroenteritis
• Interventions: Drug: micro-crystalline cellulose; Drug: LGG

• Registration Number: NCT01773967
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-23
• Study Start: 2014-07
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Results First Submitted: 2019-06-25
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-13
• Last Update Submitted: 2019-08-13
• Results First Posted: 2019-09-06
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 971

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	micro-crystalline cellulose	micro-crystalline cellulose PO bid x 5 days
LGG	LGG	LGG 10\^10 cfu PO bid x 5 days

Primary Outcome Measures

Name	Time	Method
Number of Participants With Modified Vesikari Scale Score >=9	14 days	This is a validated gastroenteritis severity score that includes duration and frequency of diarrhea, duration and frequency of vomiting, duration and frequency of fever and use of health care resources. Scores \>=9 indicate moderate-severe gastroenteritis. Higher is worse.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With LGG Bacteremia	1 month	bacteremia caused by LGG
Diarrhea Duration	14 days	diarrhea duration in hours after randomization

Trial Locations

Locations (10)

St. Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States

Children's Hospital of New York; 🇺🇸 New York, New York, United States

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

Children's Hospital of Michigan; 🇺🇸 Detroit, Michigan, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Hasbro Children's Hospital; 🇺🇸 Providence, Rhode Island, United States