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IRCT20221221056887N1 IRCT 2023-03-06 Kerman University of Medical Sciences Investigating the effect of mouthwash containing an acidophilic strain of Lactobacillus brevis enriched with selenium on the microbial flora of the gastrointestinal tract and the healing of oral ulcers in ICU patients of Shahid Bahonar Medical Center, Kerman. Investigating the effect of mouthwash containing an acidophilic strain of Lactobacillus brevis enriched with selenium on the microbial flora of the gastrointestinal tract and the healing of oral ulcers in ICU patients 2023-04-21 anticipated 60 Complete https://irct.ir/trial/68726 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 with conditions for entering the study will be divided into two equal groups, and the placement of people in these two groups will be in the form of block randomization with the blinding process (in If the total sample size is not available for block randomization at the beginning of the study, randomization using random number table method is used, Blinding description: This study has been double-blind, so that the patient, the clinical caregiver, the evaluator, and the outcome researcher do not know the type of mouthwash prescribed, and it is only prescribed based on mouthwash number 1, 2, and 3. 3 Condition 1: oral ulcer. Condition 2: Changing the flora of the digestive tract. Intervention 1: Intervention group: The studied mouthwash (produced in Kerman University of Medical Sciences, Iran, where Lactobacillus isolated from dairy and edible products is cultured in an environment containing selenium salt to be enriched with selenium, and after laboratory approval of the bacteria for human use daily 4 50 cc of normal saline 0.9% containing 109 cfu of this probiotic for 30 seconds is prescribed for patients as a mouthwash for one week. Intervention 2: Intervention group: Chlorhexidine mouthwash (manufactured by Vi One-Iran, which is diluted to a concentration of 0.12% and then 50 cc of this mouthwash is prescribed to the patients 4 times a day for 30 seconds for a week). Intervention 3: Control group: normal saline 0.9% (manufactured by Iran-Iran company, which is used at a concentration of 0.9% and 50cc of this mouthwash is prescribed to patients 4 times a day for 30 seconds for a week). 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) Being hospitalized in the ICU department of Bahnar Hospital No sepsis, pneumonia, or other active infection No known immunodeficiency For intubated patients, cases that the intubation tube is cuffed are selected 18 years no limit Both The patient was discharged from the ICU and anesthesia service of Bahnar Hospital K12.1 A09 Other forms of stomatitis Infectious gastroenteritis and colitis, unspecified Treatment - Drugs Treatment - Drugs Placebo Intervention group: The studied mouthwash (produced in Kerman University of Medical Sciences, Iran, where Lactobacillus isolated from dairy and edible products is cultured in an environment containing selenium salt to be enriched with selenium, and after laboratory approval of the bacteria for human use daily 4 50 cc of normal saline 0.9% containing 109 cfu of this probiotic for 30 seconds is prescribed for patients as a mouthwash for one week. Intervention group: Chlorhexidine mouthwash (manufactured by Vi One-Iran, which is diluted to a concentration of 0.12% and then 50 cc of this mouthwash is prescribed to the patients 4 times a day for 30 seconds for a week) Control group: normal saline 0.9% (manufactured by Iran-Iran company, which is used at a concentration of 0.9% and 50cc of this mouthwash is prescribed to patients 4 times a day for 30 seconds for a week) Oral ulcer. Timepoint: The entire duration of drug administration. Method of measurement: Observation and examination of the wound by the researcher(wound healing time AND Wound dimensions). Gastrointestinal flora. Timepoint: The beginning and the end of the study and according to the routine of the department. Method of measurement: The information available in the system and the response section of the patient's tests(Microbial flora of the pharynx). Biotechnology Development Headquarters Kerman University of Medical Sciences Biotechnology Development Headquarters Approved 2023-02-06 Ethics committee of Kerman University of Medical Sciences Jahad Blvd. Ebn Sina Avenue, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)