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

University of South Alabama (USA)

Status

Completed

Conditions

Critical Illness

Antibiotic-associated Diarrhea

Treatments

Dietary Supplement: lactobacillus GG

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06109740

08-218

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

1 day to 17 years old

Volunteers

No Healthy Volunteers

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