IRCT20190215042716N4 IRCT 2023-12-09 Shahid Beheshti University of Medical Sciences Probiotics: A Promising Strategy to Reduce gavage return Effect of probiotics in reducing gavage return in intensive care unit patients: a randomized clinical trial 2023-12-22 anticipated 60 Complete https://irct.ir/trial/74123 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization was performed using computerized randomization. In this method, a computer uses a random algorithm to assign participants to the intervention and control groups. In this study, randomization was performed as follows: 1-The name and case number of all potential patients were entered into a computerized database. 2-A random algorithm was used to assign patients to the intervention and control groups. 3-The results of randomization were kept confidential from the study team. We will use statistical software such as SAS or SPSS to generate random allocation sequence. Specifically, a randomization feature of the software will be utilized. We will create two equal groups of 30 participants by specifying group size parameters. The software has a random allocation algorithm which will assign each participant ID to either group 1 (intervention) or group 2 (control) entirely at random. This results in two groups that have participants assigned in a random order determined computationally by the software. At this stage, the two groups are randomized and researchers/participants are still blinded to the allocation (double blinding). Then the randomized group assignments will be implemented accordingly - group 1 receives probiotic capsules and group 2 receives placebo capsules for the 14 day intervention period. Final data analysis will combine all results from both groups, still in a blinded fashion. Only after statistical analysis is complete, the randomization code will be broken to determine which group was probiotic intervention vs placebo control to interpret the actual effect of the probiotic supplement, Blinding description: In this study, blinding was performed using double-blinding. In this method, participants, researchers, and other study personnel are unaware of the intervention and control groups. In this study, blinding was performed as follows: Participants were randomly assigned to intervention and control groups. Researchers and other study personnel were not informed of the results of randomization. Participants and researchers were informed of their intervention and control group through a coded system. This ensured that participants, researchers, and other study personnel were unaware of the intervention and control groups. 1-2 Gastric regurgitation. Intervention group: Probiotic group receiving Lactobacillus casei capsules "This group was randomly selected and will receive probiotic capsules containing Lactobacillus casei for 14 days.. Yes - There is a plan to make this available What will be shared: The whole potential data after being unidentifiable is published When: One year To whom: Medical Society Conditions: Contributing to studies Where to obtain: Email: n.shafigh@sbmu.ac.ir How to obtain: Tho months Comments: