Evaluation the effect of oral probiotics on enteral nutrition tolerance in patients admitted to intensive care units: a double-blind randomized controlled trial

Investigating the effect of probiotic consumption on improving oral nutrition tolerance in hospitalized patients in the intensive care unit.

This study is a prospective, double-blind, randomized controlled clinical trial (phase 2), 100 patients will randomly, Using Random allocation software (version 1.0), assign to the control or intervention group (50 in each group). The Nutritionist, student in charge of completing the questionnaires and the patient will not be notified of any grouping. In the intervention group, patients will receive Familact probiotic capsules twice daily in addition to routine care and will be followed up for 7 days. In the control group, patients will receive a placebo capsule in addition to routine care.

The gavage composition received in all patients during the study period will be the standard Intramil formula. Gastronazal tube type will be the same in all patients and number 16. The NG tube will be connected to a 60 cc syringe. All stages will be hidden from the patient, the treating physician, and the evaluators. Only the person in charge of preparing the gavage will know the type of intervention.

Inclusion criteria: 1) Age over 18 years 2) No history of GI injury during hospitalization 3) Nutrition through the nasal tube (gavage) Exclusion criteria: 1) bleeding disorders or having an INR above 2 2) drug or alcohol abuse 3) Failure to sign a written consent 4) Pregnancy and lactation

A group receiving probiotic capsules is a femme lactate and a group receiving normal care.

Delayed gastric emptying, recurrence of gastric contents into the esophagus, Frequent need for prokinetics, diarrhea (three or more loose stools in the last 24 hours), or constipation ( No stool for the past three days).

First, using Random allocation software (version 1.0), we generate a random sequence by a simple random allocation method. In this table, we specify from 1 to 64 and each number is assigned to an intervention group (A or B). The first eligible person is referred to as number 1, the second person as number 2, and so on up to 64 patients. To be blind to random allocation, patients are placed in one of the intervention groups (A or B) according to the table by a third person who is unaware of the interventions

All stages are hidden from the patient, the treating physician and the evaluators. Only the hospital's nutritionist, who is responsible for overseeing the preparation of patients' gavage, will be aware of the type of intervention. Nursing staff, physicians, and anesthesiologists will not be aware of the type of intervention. Due to the fact that both Formula Intramil powder and probiotic powder are white, it will not be possible to distinguish the type of intervention from the appearance of the product. To do this, mixing Intramill powder with probiotics or mixing Intramill powder with placebo is done in the hospital kitchen and by a nutritionist.