Critical Illness Clinical Trial
Official title:
Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit
NCT number | NCT06109740 |
Other study ID # | 08-218 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2008 |
Est. completion date | November 2012 |
Verified date | October 2023 |
Source | University of South Alabama |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | November 2012 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 17 Years |
Eligibility | 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) - NPO |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of South Alabama | Amerifit Brands Inc |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of antibiotic associated diarrhea | 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. | Full time while on antibiotics and 48 hours after | |
Secondary | Tolerability of lactobacillus GG | Assessment of any adverse events related to lactobacillus GG | 2 weeks |
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