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IRCT20180712040438N7 IRCT 2022-12-06 Kermanshah University of Medical Sciences The effects of Postbiotic in CVA patients 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 2022-12-21 anticipated 60 Complete https://irct.ir/trial/67055 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 stroke. Intervention 1: Intervention group: 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 per day for 7 days. Intervention 2: Control group: Patients in the second group of placebo containing maltodextrin will be prescribed one sachet per day for 7 days. Yes - There is a plan to make this available What will be shared: Information related to the main results will be shared When: Accessibility to data is possible 8 months after publication To whom: The data will only be available for people working in academic institutions Conditions: The data of the present study will only be accessible by other researchers, for conducting Meta analysis Where to obtain: Dr. Jalal Mokudi, Faculty of Nutrition and Food Sciences, Kermanshah University of Medical Sciences Email: jmoludi@yahoo.com 0098 9399516760 How to obtain: 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 Comments:
public Jalal Moludi
Kermanshah Province, Kermanshah City, Isar Square, next to Farabi Hospital, Faculty of Nutrition Sciences and Food Industry
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2003 jmoludi@yahoo.com Kermanshah University of Medical Sciences scientific Dr Jalal Moludi
Faculty of Nutrition and Food Technology, Next to Farabi Hospital
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2008 jmoludi@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Patients with stroke and under mechanical ventilation admitted to the intensive care unit Age eighteen and older BMI= 18.5- 30 Written consent from relatives The patient has a tracheal tube and is under mechanical ventilation and it continues for 72 hours, and 48 hours have not passed since the patient's intubation and feeding should start within the next 24 hours. 18 years no limit Both pregnancy Weakening of the immune system for any reason receiving heart valve replacement vascular graft immune system suppressants 164 Stroke, not specified as haemorrhage or infarction Treatment - Drugs Placebo Intervention group: 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 per day for 7 days. Control group: Patients in the second group of placebo containing maltodextrin will be prescribed one sachet per day for 7 days Duration of hospitalization in ICU. Timepoint: From the beginning of the study to the 28th day. Method of measurement: patient file. Improving the composition of the intestinal microbiota. Timepoint: Before and after the intervention. Method of measurement: Via real time PCR. BUN. Timepoint: At the time of patient admission, day 7, day 14 and day 28. Method of measurement: Enzymatic method. Cr. Timepoint: At the time of patient admission, day 7, day 14 and day 28. Method of measurement: Enzymatic method. Serum levels of hs-CRP. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA. Serum levels of ESR. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA. Serum levels of interleukin 6. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA. Serum levels of interleukin 10. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA. Improvement of nutritional status. Timepoint: NUTRIC scoring system. Method of measurement: At the beginning of admission and on the 28th day. TAC. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA. MDA. Timepoint: At the beginning of admission and on the 28th day. Method of measurement: ELISA. Survival rate of patients in the ICU. Timepoint: From the beginning of admission to the 28th day. Method of measurement: Using patient records. Duration of hospitalization. Timepoint: From the beginning of admission to the 28th day. Method of measurement: Using patient records. Duration of intubation. Timepoint: From the beginning of admission to the 28th day. Method of measurement: Using patient records. Mortality rate. Timepoint: From the beginning of admission to the 28th day. Method of measurement: Using patient records. Kermanshah University of Medical Sciences Approved 2022-10-22 Ethics Committee of Kermanshah University of Medical Sciences Faculty of Nutrition and Food Technology, Next to Farabi Hospital, Kermanshah, Iran kermanshah Kermanshah Iran (Islamic Republic of)