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

Sponsor

University of South Alabama (Other)

Overall Status

Completed

CT.gov ID

NCT06109740

Collaborator

Amerifit Brands Inc (Industry)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Antibiotic-associated Diarrhea	Dietary Supplement: lactobacillus GG	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Prospective randomized, double-blind, placebo-controlled crossover trialProspective randomized, double-blind, placebo-controlled crossover trial

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Matching placebo. Dispensed from pharmacy.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactobacillus GG Probiotic nutritional supplement	Dietary Supplement: lactobacillus GG probiotic
Placebo Comparator: Placebo capsule Matching placebo capsule	Dietary Supplement: lactobacillus GG probiotic

Arm

Intervention/Treatment

Experimental: Lactobacillus GG

Probiotic nutritional supplement

Dietary Supplement: lactobacillus GG

probiotic

Placebo Comparator: Placebo capsule

Matching placebo capsule

Dietary Supplement: lactobacillus GG

probiotic

Outcome Measures

Primary Outcome Measures

Incidence of antibiotic associated diarrhea [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 Outcome Measures

Tolerability of lactobacillus GG [2 weeks]
Assessment of any adverse events related to lactobacillus GG

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 17 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of South Alabama
Amerifit Brands Inc

Investigators

Principal Investigator: Allison Chung, University of South Alabama

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Allison Chung, Associate Professor, University of South Alabama

ClinicalTrials.gov Identifier:

NCT06109740

Other Study ID Numbers:

08-218

First Posted:

Oct 31, 2023

Last Update Posted:

Oct 31, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Allison Chung, Associate Professor, University of South Alabama

Pediatric

PICU

Additional relevant MeSH terms:

Diarrhea

Critical Illness

Study Results

No Results Posted as of Oct 31, 2023