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

Not Applicable

Completed

• Conditions: Antibiotic-associated Diarrhea; Critical Illness
• Interventions: Dietary Supplement: lactobacillus GG

• Registration Number: NCT06109740
• Lead Sponsor: University of South Alabama

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.

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.

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2011-10
• Study Completion: 2012-11
• Status Verified: 2023-10
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-25
• Last Update Submitted: 2023-10-25
• Study First Posted: 2023-10-31
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Admitted to PICU
• Requiring > 72 hrs of antibiotic therapy
• < 17 years
• Able to administer oral LGG or placebo

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lactobacillus GG	lactobacillus GG	Probiotic nutritional supplement
Placebo capsule	lactobacillus GG	Matching placebo capsule

Primary Outcome Measures

Name	Time	Method
Incidence of antibiotic associated diarrhea	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 Outcome Measures

Name	Time	Method
Tolerability of lactobacillus GG	2 weeks	Assessment of any adverse events related to lactobacillus GG