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

NCT06109740 | Completed

• 1 other identifier: 08-218
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Illness; Antibiotic-associated Diarrhea

Keywords

Pediatric; PICU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tolerability of lactobacillus GG

  2 weeks

Study Arms (2)

Lactobacillus GG

EXPERIMENTAL

Probiotic nutritional supplement

Dietary Supplement: lactobacillus GG

Placebo capsule

PLACEBO COMPARATOR

Matching placebo capsule

Dietary Supplement: lactobacillus GG

Interventions

lactobacillus GG DIETARY_SUPPLEMENT

probiotic

Lactobacillus GG; Placebo capsule

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Alabama: lead
• Amerifit Brands Inc: collaborator

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Allison Chung

  University of South Alabama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Matching placebo. Dispensed from pharmacy.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective randomized, double-blind, placebo-controlled crossover trial

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 31, 2023
• Study Start: October 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2012
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share