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

Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773967
• Other study ID #: 1R01HD071915
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2014
• Est. completion date: August 2018

Study information

• Verified date: August 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Other known NCT identifiers

• NCT00970164

Recruitment information / eligibility

• Status: Completed
• Enrollment: 971
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 48 Months

Eligibility

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).

Related Conditions & MeSH terms

• Emergencies
• Gastroenteritis

Intervention

Drug:
• LGG
LGG 10^10 cfu PO BID X 5 days
• micro-crystalline cellulose
1 capsule PO bid x 5 days

Locations

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

Sponsors (11)

Lead Sponsor	Collaborator
Washington University School of Medicine	Brown University, Children's Hospital Medical Center, Cincinnati, Children's Research Institute, Columbia University, Northwestern University, University of California, Davis, University of Michigan, University of New Mexico, University of Utah, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Modified Vesikari Scale Score >=9	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.	14 days
Secondary	Number of Participants With LGG Bacteremia	bacteremia caused by LGG	1 month
Secondary	Diarrhea Duration	diarrhea duration in hours after randomization	14 days