Effect of probiotics in reducing gavage return in intensive care unit patients: a randomized clinical trial

The objective of the study is to investigate the effectiveness of probiotics in reducing the incidence and severity of gastroesophageal reflux, vomiting, and diarrhea in adult Intensive Care Unit (ICU) patients who require enteral nutrition.

This study is a randomized, double-blind clinical trial in which participants are randomly assigned to two groups: Group 1: Participants in this group will receive one capsule containing Lactobacillus casei daily. Group 2: Participants in this group will receive one capsule containing a placebo daily. The study will last for 14 days. At the end of the study, researchers will assess the incidence and severity of adverse events in both groups.

This study is a randomized, double-blind, placebo-controlled clinical trial that will be conducted at the Labbafinejad Hospital in Tehran, Iran. Participants in the study will be hospitalized patients in the intensive care unit (ICU) who are receiving enteral nutrition, which is a type of nutrition that is delivered through a tube inserted into the stomach or intestines.

Inclusion Criteria: 1-En Adult patients (18 years of age or older) admitted to the intensive care unit (ICU) 2-Patients requiring tube feeding 3-Patients with symptoms of gastroesophageal reflux (GERD), such as vomiting, diarrhea, nausea, etc. Exclusion criteria: 1-En Presence of underlying GI disease 2-Prior antibiotic use 3-Known allergy to probiotic ingredients 4-Pregnancy or lactation 5-Coagulation disorders or thrombocytopenia

Probiotic group receiving Lactobacillus casei capsules" This group was randomly selected and will receive probiotic capsules containing Lactobacillus casei for 14 days.

Incidence and severity of regurgitation, vomiting, and diarrhea"

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.

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.

The whole potential data after being unidentifiable is published

One year

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Contributing to studies

Email: n.shafigh@sbmu.ac.ir

Tho months