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IRCT20091012002582N19 IRCT 2018-05-09 Tabriz University of Medical Sciences Effect of a Lactocare, on gut microbs in critically ill septic patients admitted to intensive care units Effect of a probiotic supplementation, Lactocare, on gut microbiota in critically ill septic patients admitted to intensive care units 2018-06-22 anticipated 40 Complete https://irct.ir/trial/30361 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned into two groups by block randomization. Randomization is done based on the Grav O tron2.0 software, Blinding description: In this study, the participants, the main researcher, the health care staff (doctors, nurses, etc.) responsible for patient care, data collection authorities, those who evaluate the outcome, and those who prepare the draft article. Have been kept blind to the study groups. 3 Other infectious diseases. Intervention 1: Intervention group: En All patients in intervention group will receive enteral capsules of Lactocare (1 capsule/12h) for 10 days in addition to standard ICU treatment. Intervention 2: Control group: All patients in control group will receive standard ICU treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because the completion of the data of questionnaire is manual and is not recorded anywhere.
public Ata Mahmoodpoor
Faculty of Medicine, Golgasht street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3332 8009 mahmoodpoora@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Ata Mahmoodpoor
Faculty of Medicine, Golgasht street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3332 8009 mahmoodpoora@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Need for enteral nutrition Age over 18 years old Age under 70 years old 18 years 70 years Both age under 18 years old age over 70 years old pregnancy lactating previous history of lactocare use Long-term administration of systemic corticosteroid History of alcohol consumption History of intestinal surgery in a recent month B99.8 Other infectious disease Treatment - Drugs Treatment - Drugs Intervention group: En All patients in intervention group will receive enteral capsules of Lactocare (1 capsule/12h) for 10 days in addition to standard ICU treatment. Control group: All patients in control group will receive standard ICU treatment. Gut microbiota in critically ill septic patients admitted to intensive care units. Timepoint: En days 1th and 10th. Method of measurement: PCR of stool. En ICU length of stay. Timepoint: En during ICU stay. Method of measurement: En days that patient is stayed in ICU. Tabriz University of Medical Sciences Approved 2017-12-04 Ethics committee of Tabriz University of Medical Sciences Central Building No. 2, Tabriz University of Medical Sciences, Golghast St, Tabriz East Azarbaijan Iran (Islamic Republic of)