Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit

Critical Illness Clinical Trial

Official title:

Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06109740
• Other study ID #: 08-218
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Antibiotic-associated Diarrhea
• Critical Illness
• Diarrhea

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