Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of South Alabama
- Enrollment
- 21
- Primary Endpoint
- Incidence of antibiotic associated diarrhea
Study Overview
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 preventing antibiotic associated diarrhea in the PICU
- Is lactobacillus safe in critically ill pediatric patients Participants will be randomized to lactobacillus GG vs placebo while on antibiotics
If there is a comparison group: Researchers will compare lactobacillus GG to see if it prevents antibiotic associated diarrhea.
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-controlled trial
Setting:
15-20 bed PICU at University of South Alabama, Children's and Women's Hospital in Mobile, Alabama.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Matching placebo. Dispensed from pharmacy.
Eligibility Criteria
- Ages
- 1 Day to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Admitted to PICU
- •Requiring > 72 hrs of antibiotic therapy
- •< 17 years
- •Able to administer oral LGG or placebo
Exclusion Criteria
- •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)
Arms & Interventions
Placebo capsule
Matching placebo capsule
Intervention: lactobacillus GG (Dietary Supplement)
Lactobacillus GG
Probiotic nutritional supplement
Intervention: lactobacillus GG (Dietary Supplement)
Outcomes
Primary Outcomes
Incidence of antibiotic associated diarrhea
Time Frame: Full time while on antibiotics and 48 hours after
Diarrhea was defined as stools \>200 mL or 200 g per day in patients over 10 kg and \> 20 mL/kg/day or \> 20 g/kg/day in patients \< 10 kg or 3 or more loose stools in 24 hours if the stools were not able to be weighed. When patients developed diarrhea lasting more than 72 hours, they were crossed over to the alternate treatment arm.
Secondary Outcomes
- Tolerability of lactobacillus GG(2 weeks)
Investigators
Allison Chung
Associate Professor
University of South Alabama