Critical Illness Clinical Trial
Official title:
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04551508 -
Delirium Screening 3 Methods Study
|
||
| Recruiting |
NCT06037928 -
Plasma Sodium and Sodium Administration in the ICU
|
||
| Completed |
NCT03671447 -
Enhanced Recovery After Intensive Care (ERIC)
|
N/A | |
| Recruiting |
NCT03941002 -
Continuous Evaluation of Diaphragm Function
|
N/A | |
| Recruiting |
NCT04674657 -
Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
|
||
| Completed |
NCT04239209 -
Effect of Intensivist Communication on Surrogate Prognosis Interpretation
|
N/A | |
| Completed |
NCT05531305 -
Longitudinal Changes in Muscle Mass After Intensive Care
|
N/A | |
| Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
| Completed |
NCT02916004 -
The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.
|
N/A | |
| Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
| Completed |
NCT04479254 -
The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)
|
N/A | |
| Recruiting |
NCT04475666 -
Replacing Protein Via Enteral Nutrition in Critically Ill Patients
|
N/A | |
| Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
| Not yet recruiting |
NCT04516395 -
Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae
|
N/A | |
| Withdrawn |
NCT04043091 -
Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction
|
N/A | |
| Recruiting |
NCT02989051 -
Fluid Restriction Keeps Children Dry
|
Phase 2/Phase 3 | |
| Recruiting |
NCT02922998 -
CD64 and Antibiotics in Human Sepsis
|
N/A | |
| Completed |
NCT02899208 -
Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?
|
N/A | |
| Completed |
NCT03048487 -
Protein Consumption in Critically Ill Patients
|
||
| Recruiting |
NCT02163109 -
Oxygen Consumption in Critical Illness
|