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

NCT ID: NCT06109740

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-11-30

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.

Conditions

Critical Illness; Antibiotic-associated Diarrhea

Keywords

Pediatric; PICU

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lactobacillus GG

Probiotic nutritional supplement

Group Type: EXPERIMENTAL

lactobacillus GG

Intervention Type: DIETARY_SUPPLEMENT

probiotic

Placebo capsule

Matching placebo capsule

Group Type: PLACEBO_COMPARATOR

lactobacillus GG

Intervention Type: DIETARY_SUPPLEMENT

probiotic

Interventions

lactobacillus GG

probiotic

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amerifit Brands Inc

INDUSTRY

Sponsor Role: collaborator

University of South Alabama

OTHER

Sponsor Role: lead

Responsible Party

Allison Chung

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison Chung

Role: PRINCIPAL_INVESTIGATOR

University of South Alabama

Other Identifiers

08-218

Identifier Type: -

Identifier Source: org_study_id