Clinical trial NCT06109740: Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit
Official title: Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Antibiotic-associated Diarrhea
Keywords: Pediatric
PICU
Lead sponsor: University of South Alabama
Sponsor class: OTHER
Collaborators: name: Amerifit Brands Inc
First posted: 2023-10-31
Enrollment: 21
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective randomized, double-blind, placebo-controlled crossover trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of antibiotic associated diarrhea
timeFrame: Full time while on antibiotics and 48 hours after
Secondary outcomes:
measure: Tolerability of lactobacillus GG
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of South Alabama
name: Allison Chung
role: PRINCIPAL_INVESTIGATOR
References: