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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2023
Source University of South Alabama
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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. Patients: Pediatric patients ≤ 17 years and required antibiotic therapy ≥ 72hrs were randomized to receive placebo or control (lactobacillus GG). Exclusion criteria included but was not limited to antibiotics ≥ 48 hours prior, prior probiotics, pre-existing diarrhea, laxative therapy, immunocompromise, and GI disorders. Interventions: Treatment with LGG (30 x 109 CFU) or a matching placebo capsule was administered twice daily, initiated within 24 hours of starting antibiotic therapy and continued for the duration of therapy. Measurements: Diarrhea was defined as stools >200 mL or 200 g per day in a patient over 10 kg and > 20 mL/kg/day or > 20 g/kg/day in a patient < 10 kg or 3 or more loose stools in 24 hours.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
lactobacillus GG
probiotic

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of South Alabama Amerifit Brands Inc

Outcome

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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