Status:
COMPLETED
Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit
Lead Sponsor:
University of South Alabama
Collaborating Sponsors:
Amerifit Brands Inc
Conditions:
Critical Illness
Antibiotic-associated Diarrhea
Eligibility:
All Genders
1-17 years
Phase:
NA
Brief Summary
The goal of this prospective trial is to learn about lactobacillus use in critically ill pediatric patients. The main question\[s\] it aims to answer are: * Is lactobacillus GG effective in preventin...
Detailed Description
The objective of this study was to assess the efficacy of lactobacillus GG (LGG) to prevent antibiotic-associated diarrhea (AAD) in the PICU. Design: Prospective randomized, double-blind, placebo-co...
Eligibility Criteria
Inclusion
- Admitted to PICU
- Requiring \> 72 hrs of antibiotic therapy
- \< 17 years
- Able to administer oral LGG or placebo
Exclusion
- Antibiotics 48 hours prior to hospital admission
- Probiotic use within 7 days of admission
- Pre-existing diarrhea at time of hospital admission or 24 hours prior to admission
- Laxative therapy at time of admission or 48 hours prior to admission
- HIV with CD4 \< 250
- Established immunologic deficiencies (ANC \< 100)
- Chronic steroid therapy ( \> 10 days)
- GI disorders including intussusception, lower bowel disease, bowel resection, irritable bowel syndrome, ulcerative colitis, or Crohn's disease
- Status post-surgical patients with antibiotic prophylaxis (\< 72 hours duration)
- NPO
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06109740
Start Date
October 1 2008
End Date
November 1 2012
Last Update
October 31 2023
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