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IRCT20221221056887N2 IRCT 2023-05-12 Biotechnology Development Headquarters Investigating the effect of an acidophilic Lactobacillus brevis strain enriched with selenium on bedsores of ICU patients of Shahid Bahonar Medical Center, Kerman Investigating the effect of an acidophilic Lactobacillus brevis strain enriched with selenium on bedsores of ICU patients 2023-05-22 anticipated 40 Complete https://irct.ir/trial/68885 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After examining the patients in terms of the criteria for entering the study and obtaining informed consent, the total number of people eligible to enter the study will be divided into two equal groups of 40 people, and the placement of people in these two groups will be done by block randomization along with the blinding process. It was like this that in the randomization, people are placed in two groups randomly and completely randomly, and in order to equalize the number of people in the two groups, block randomization will be done if needed (if the total sample size at the beginning of the study for If block randomization is not available, then randomization is used by the random number table method in such a way that we divide the number of people into two groups based on the random number table, Blinding description: This study has been double-blind in that the patient himself does not know the type of capsule received, and also the treatment staff such as the clinical supervisor and project researchers such as the evaluator of the investigated factors and the outcome researcher do not know the type of capsule prescribed and only based on Capsule number 1 and 2 are prescribed and will be determined at the time of data analysis. 2-3 bedsores. Intervention 1: Intervention group: studied probiotic (probiotic capsule - containing 109 cfu of Lactobacillus isolated from dairy and edible products, which is cultured in an environment containing selenium salt to be enriched with selenium, and after laboratory confirmation of the bacteria, it is used in the study for human use - manufacturing Kerman University of Medical Sciences - Iran, which is prescribed to the patient once a day for 2 weeks, and if the patient is intubated, it is given to the patient through the NG tube, which is installed in the ward for patients with reduced level of consciousness. Intervention 2: Control group: Placebo (Placebo capsule or placebo contains 50 grams of maltodextrin made in Iran, which is prescribed to the patient once a day for 2 weeks, and if the patient is intubated, it is inserted through the NG tube in the ward for patients with reduced level of consciousness. is given to the patient). Yes - There is a plan to make this available What will be shared: Project data will be published without mentioning personal information and identification of study subjects When: Access starts from the publication of the final report To whom: The data that can be published is published in the form of a final report and is available to everyone Conditions: The data that can be published will be announced in the final report of the plan Where to obtain: Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran How to obtain: After the completion of the project (1 year) Comments:
public Farshid Ataollahi
Qaraney St, Next to Shahid Bahonar Hospital, Upper Floor 0f Pharmacy No.2 , Kerman, Iran
Kerman Iran (Islamic Republic of) 7616911319 +98 34 3223 8942 farshid.ataollahi@gmail.com Kerman University of Medical Sciences scientific Farshid Ataollahi
Qaraney St, Next to Shahid Bahonar Hospital, Upper Floor 0f Pharmacy No.2 , Kerman, Iran
Kerman Iran (Islamic Republic of) 7616911319 +98 34 3223 8942 farshid.ataollahi@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) having bedsores (stage 1 and 2) Not receiving other probiotics Being hospitalized in the ICU department of Bahnar Hospital Not having sepsis, pneumonia, other active infection and known immunodeficiency 18 years no limit Both The patient was discharged from the ICU and anesthesia service of Bahnar Hospital L89 Pressure ulcer Treatment - Drugs Placebo Intervention group: studied probiotic (probiotic capsule - containing 109 cfu of Lactobacillus isolated from dairy and edible products, which is cultured in an environment containing selenium salt to be enriched with selenium, and after laboratory confirmation of the bacteria, it is used in the study for human use - manufacturing Kerman University of Medical Sciences - Iran, which is prescribed to the patient once a day for 2 weeks, and if the patient is intubated, it is given to the patient through the NG tube, which is installed in the ward for patients with reduced level of consciousness. Control group: Placebo (Placebo capsule or placebo contains 50 grams of maltodextrin made in Iran, which is prescribed to the patient once a day for 2 weeks, and if the patient is intubated, it is inserted through the NG tube in the ward for patients with reduced level of consciousness. is given to the patient) Bedsore. Timepoint: The entire duration of drug administration. Method of measurement: Observation and examination of the wound by the researcher (wound healing time, wound dimensions and wound stage). Kerman University of Medical Sciences Biotechnology Development Headquarters Kerman University of Medical Sciences Approved 2023-05-01 Ethics committee of Kerman University of Medical Sciences Jahad Blvd. Ebn Sina Avenue, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)