Introduction: This study is a randomized, double-blind, placebo-controlled clinical trial aimed at investigating the effectiveness of probiotics in reducing gavage reflux in Intensive Care Unit (ICU) patients. The study population includes adult ICU patients requiring enteral nutrition. Patients are randomly divided into two groups: intervention (receiving probiotic) and control (receiving placebo). The primary outcomes are the incidence and severity of gavage reflux, vomiting, and diarrhea. Secondary outcomes include the duration of mechanical ventilation and ICU stay. Patients' demographic and clinical information is recorded, and data are analyzed using appropriate statistical tests. It is expected that probiotics will significantly reduce gavage reflux and improve other outcomes in ICU patients. The results of this study could be useful in developing clinical guidelines and improving nutritional care for this group of patients. Methodology: This is a randomized, double-blind, placebo-controlled clinical trial conducted in the Intensive Care Unit (ICU) of Labbafinejad Hospital. Inclusion criteria include: Adult patients (age over 18 years) admitted to the ICU requiring enteral nutrition. Exclusion criteria are: Known allergy to probiotics, inflammatory bowel disorders, and antibiotic use in the past 2 weeks. Eligible patients are randomly assigned to intervention and control groups using a random number table. The intervention group receives a daily probiotic capsule containing 10 billion live colonies of Lactobacillus rhamnosus GG along with enteral nutrition. The control group receives a placebo capsule similar to the probiotic. The primary outcome is the incidence and severity of gavage reflux, which is graded based on the volume of daily reflux contents. Secondary outcomes include the incidence of vomiting, diarrhea, duration of mechanical ventilation, and length of ICU stay. Demographic, clinical, and outcome data are collected by researchers blinded to the treatment group. Data will be analyzed using SPSS software. Independent t-test will be used for comparing quantitative variables, and chi-square test for qualitative variables. Conclusion:The results of this clinical trial showed that daily administration of Lactobacillus rhamnosus GG probiotic to ICU patients receiving enteral nutrition significantly reduced the incidence and severity of gavage reflux compared to the placebo group. Additionally, the probiotic group experienced lower rates of vomiting and diarrhea.
