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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Critical Illness, Antibiotic-associated Diarrhea

Intervention / Treatment
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* Dietary Supplement: lactobacillus GG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective randomized, double-blind, placebo-controlled crossover trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus GG<br>Probiotic nutritional supplement | Dietary Supplement: lactobacillus GG<br>* probiotic<br>|
| Placebo Comparator: Placebo capsule<br>Matching placebo capsule | Dietary Supplement: lactobacillus GG<br>* probiotic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of lactobacillus GG | Assessment of any adverse events related to lactobacillus GG | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, PICU