The effects of Postbiotic supplementation on Gut microbiota profiles and clinical factors in CVA patients under mechanical ventilation admitted to intensive care unit: a clinical trial

Effect of Posbiotics supplement on intestinal microbiota and clinical outcomes in patients with stroke and under mechanical ventilation hospitalized in the ICU

Clinical trial study with parallel groups, double-blind, with placebo, one control group, randomized using blocking method, phase 3, on 60 patients

Eligible patients to enter the study are selected from among those who refer to Imam Reza Hospital (AS), which is under the supervision of Kermanshah University of Medical Sciences. 120 patients suffering from cerebral stroke and under mechanical ventilation admitted to the ICU, whose illness was confirmed by the relevant specialist (in Imam Reza (AS) hospital, which is under the supervision of Kermanshah University of Medical Sciences), after completing the consent form by the companion First-grade patients will enter the study.

Patients suffering from stroke and under mechanical ventilation hospitalized in the intensive care unit, aged eighteen years and older; BMI = 18.5-30 will be included in the study, but pregnancy; Weakening of the immune system for any reason, receiving immune system suppressants, heart valve replacement; Vascular graft is one of the exclusion criteria.

Patients in the first group will be prescribed Lactobacillus paracasei postbiotic supplement (containing short-chain fatty acids and exopolysaccharides) in the amount of 2000 mg, and in the second group, a placebo containing maltodextrin will be prescribed one sachet per day for 7 days.

Duration of hospitalization in ICU, Firmicutes Bacteroidetes Ratio), BUN, Cr, TAC and MDA levels, reduction in the incidence of ventilator-associated pneumonia and the survival rate of patients in the ICU department, duration of hospitalization, duration of Intubation and 28-day mortality

The randomization method in this study is block randomization, the random sequence is generated by a statistical consultant. The registration of people is done by the project manager. Allocating people to groups is done by the statistics consultant. The team leader is different from the outcome assessor, and the team leader is not involved in the process of collecting information and evaluating the outcome, and this work will be done by trained evaluators. For random allocation of people, 6 blocks with 4 permutations will be created in the following order: 1=AABB 2=ABAB 3=ABBA 4=BABA 5=BBAA 6=BAAB where A represents the postbiotic group and B represents the placebo group. Then, based on the numbers in the random table, a number will be chosen randomly, and based on the last digit on the right, one of the groups will be used to determine the sequence of randomization. It should be noted that if the number on the right side is zero or 7 to 9 when choosing a random number, that number will not be considered and a random number will be selected again. This work will continue until all 104 people are assigned to two groups. It should be noted that this method will prevent the unbalance of the two groups as well as the identification of the randomization sequence, and the ratio of 1:1 will be observed in the two groups. It is registered and the cards are placed in the envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box respectively. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.

This clinical trial will be blinded at 3 levels (patient, outcome assessor, analyst). For blinding, it will be arranged that a code will be assigned to each drug package, which can only be identified by an independent person and the patient, the person who collects the data and the statistical analyzer, from what judgment the patient has taken. will be unaware.

Information related to the main results will be shared

Accessibility to data is possible 8 months after publication

The data will only be available for people working in academic institutions

The data of the present study will only be accessible by other researchers, for conducting Meta analysis

Dr. Jalal Mokudi, Faculty of Nutrition and Food Sciences, Kermanshah University of Medical Sciences Email: jmoludi@yahoo.com 0098 9399516760

The applicator can send a request to the person responsible for the study by email and within 10 days the document will be sent to the requesting person