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OpenTrials
Completed

NCT Number: NCT06109740

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

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.

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Key information

Age range

1 day–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus GG

Dietary Supplement

probiotic

Primary outcomes

  1. Incidence of antibiotic associated diarrhea

    Time frame: 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 outcomes

  1. Tolerability of lactobacillus GG

    Time frame: 2 weeks

    Assessment of any adverse events related to lactobacillus GG

Sponsors and collaborators

Lead sponsor

University of South Alabama

Other

Collaborators

  • Amerifit Brands Inc

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Oct 31, 2023
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.