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IRCT20100209003320N18 IRCT 2020-09-07 Tabriz University of Medical Sciences ٍEffect of probiotic on immune system and oxidative stress in intensive care unit patients The effect of seven-strain probiotic supplementation on some of the Thelpers, ICAM, VCAM, prooxidant-antioxidant balance, oxidative stress and inflammatory biomarkers and nutritional status in patients with head trauma admitted to intensive care unit: a randomized controlled clinical trial 2020-09-20 anticipated 46 Complete https://irct.ir/trial/50722 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 46 eligible patients will be randomly allocated to intervention and placebo groups using a software generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study, Blinding description: In this study, the investigators, patients, those responsible for patient enrollment, administration of the intervention, and assessors (nurses) will be blinded to the type of the supplement (probiotic or placebo) received by each group. The person responsible for preparing the supplement capsules (who is completely unrelated to the study) will be asked to assign a three-digit code to each of the two capsules (probiotic and placebo) and keep the codes for himself until the end of the study and data analysis. N/A Head Trauma. Intervention 1: Intervention group: Patients in this group will receive a probiotic supplement for 14 days. The supplement is: a capsule containing seven types of probiotics (produced by Zist takhmir Company made in Iran) and consumed four times a day (every 6 hours). Intervention 2: Control group: Patients in this group will receive a placebo for 14 days. Placebo contains maltodextrin (product of Zist takhmir Company made in Iran) and will be consumed four times a day (every 6 hours). Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: Access starting 12 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. Mehrangize Ebrahimi mamagani - Email: ebrahimimamagani@tbzmed.ac.ir- Tel: 00989141005681 How to obtain: The applicant should provide a brief description of the aims and methods of his his Meta-analysis. His request will be assessed and, if agreed, the data will be emailed to the applicant. All these procedures will take no longer than 15 days. Comments:
public Mehrangiz Ebrahimi Mamagani
Golgasht St
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7580 ebrahimimamagani@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Mehrangiz Ebrahimi-Mameghani
خیابان گلگشت، خیابان عطار نیشابوری، دانشکده تغذیه و علوم غذایی
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7580 ebrahimimamagani@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Age 60 to 18 years Low level of consciousness (GCS <8) Nutrition through the nasal - stomach tube Willingness to cooperate by obtaining the consent of first-degree relatives Patients receiving gavage Presence in the intensive care unit for at least 14 days Having an APACHE II score of 15–30 18 years 60 years Both Pregnancy- Breastfeeding Parental nutrition (more than two days) Taking immunosuppressive medications Unstable hemodynamics Intestinal obstruction; intestinal ischemia; short bowel syndrome G44.31 Acute post-traumatic headache Treatment - Drugs Placebo Intervention group: Patients in this group will receive a probiotic supplement for 14 days. The supplement is: a capsule containing seven types of probiotics (produced by Zist takhmir Company made in Iran) and consumed four times a day (every 6 hours). Control group: Patients in this group will receive a placebo for 14 days. Placebo contains maltodextrin (product of Zist takhmir Company made in Iran) and will be consumed four times a day (every 6 hours). Th-17, T-regulatory, Th10 cells. Timepoint: Beginning and end of the trial. Method of measurement: Flowcytometry. Duration of hospitalization and rate of attenuation. Timepoint: Daily. Method of measurement: Observation and questionnaire. Respiratory tract infection. Timepoint: Beginning and end of the trial. Method of measurement: Sputum Culture. Serum levels of TGF-β. Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Serum levels of IL-6. Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Serum levels of IL-1β. Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Level of consciousness and severity of the disease. Timepoint: Daily. Method of measurement: GCS , APACHE and SOFA Questionnaire. Weight. Timepoint: Beginning and end of the trial. Method of measurement: Calculation based on formula. Body mass index. Timepoint: Beginning and end of the trial. Method of measurement: Calculation based on formula. Energy, macronutrients and antioxidant nutrients (vitamins A, E, C, selenium, zinc and copper) intake. Timepoint: Beginning and end of the trial. Method of measurement: Food record (gavage) - Nutritionist 4 software. Intercellular adhesion molecule-1 (ICAM-1). Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Vascular cell adhesion molecule 1 (VCAM-1). Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Pro-oxidant-Antioxidant Balance (PAB). Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Total antioxidant capacity (TAC). Timepoint: Beginning and end of the trial. Method of measurement: Spectrophotometric method. Malondialdehyde (MDA). Timepoint: Beginning and end of the trial. Method of measurement: Spectrophotometric method. Nitric oxide (NO). Timepoint: Beginning and end of the trial. Method of measurement: ELISA. َArylesterase (ARE) activity. Timepoint: Beginning and end of the trial. Method of measurement: Spectrophotometric method. Tabriz University of Medical Sciences Approved 2020-08-10 The Research Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neishabouri Ave, Golgasht St Tabriz East Azarbaijan Iran (Islamic Republic of)