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IRCT20110510006431N4 IRCT 2022-02-16 Shahid Beheshti University of Medical Sciences Effect of probiotics on gut microbiome and pain The effect of probiotic supplementation on gut microbiome composition and postoperative pain in patients undergoing open heart surgery 2022-01-21 anticipated 80 Complete https://irct.ir/trial/61093 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, patients are divided into 2 intervention groups (as probiotic supplement group) and control group (as placebo group) (named groups A and B), to randomly assign patients to two groups of methods. Stratified blocked randomization is used. The division of branches is based on gender, so that patients are first classified into two groups based on gender: male and female (as 2 to Strata). After specifying the quadruple blocks in different arrangements (AABB, ABAB, ABBA, etc.), the lottery method with placement is used to determine the treatment allocation list. It is also necessary to explain that in order to observe the concealment in the mentioned plan, the randomization operation is performed by a person other than the main researcher and the codes specified in the packets in the package after randomization are provided to the researchers for random sampling and assignment. Placed in the intervention or control group, Blinding description: The study is double blind. A person other than the researcher who has no information about how to perform and the purpose of the study will use a list of random numbers to encode the probiotic supplement and placebo and will be numbered according to the list so that the researcher does not know The type of supplements should be observed by each group. Participants will also have no information about the contents of the package. N/A The amount of pain after open heart surgery. Intervention 1: Intervention group: Familact supplement of bio-fermentation company contains probiotic mixture including 7 stable and frozen strains: Lactobacillus acidophilus CFU (109 × 2), Lactobacillus bulgaricus CFU (108 × 2 (, Lactobacillus ramensus CFU) (Cactus 1), Cactus 109) 109 × 7), Streptococcus thermophilus CFU (1010 × 1.5), Bifidobacterium langum CFU (109 × 7), Bifidobacterium bruvii CFU (1010 × 2) and the prebiotic fructose oligosaccharide will be part of its probiotic activity. 1 gram per day for 14 days. Intervention 2: Control group: Capsules containing starch are quite similar to probiotic capsules,1 gram per day for 14 days. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 3 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Obtain permission and retain the original source name Where to obtain: shadnoush@sbmu.ac.ir How to obtain: Email to the corresponding author Comments:
public Mahdi Shadnoush
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1985738883 +98 21 2240 1423 shadnoush@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mahdi Shadnoush
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1985738883 +98 21 2240 1423 shadnoush@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study and completion of informed written consent People who, at the discretion of a cardiologist, need open heart surgery Age over 40 years Lack of gastrointestinal sensitivity to probiotics Body mass index greater than 18 Do not drink alcohol or use drugs and anti-inflammatory drugs Do not take multivitamin and mineral supplements, do not take clozapine, theophylline, caffeine, phenacetine and tacrine Do not take interfering drugs on the surface of the intestinal microbiome 40 years no limit Both Rehabilitation Rehabilitation Intervention group: Familact supplement of bio-fermentation company contains probiotic mixture including 7 stable and frozen strains: Lactobacillus acidophilus CFU (109 × 2), Lactobacillus bulgaricus CFU (108 × 2 (, Lactobacillus ramensus CFU) (Cactus 1), Cactus 109) 109 × 7), Streptococcus thermophilus CFU (1010 × 1.5), Bifidobacterium langum CFU (109 × 7), Bifidobacterium bruvii CFU (1010 × 2) and the prebiotic fructose oligosaccharide will be part of its probiotic activity. 1 gram per day for 14 days Control group: Capsules containing starch are quite similar to probiotic capsules,1 gram per day for 14 days The degree of pain. Timepoint: Immediately after regaining consciousness, 12 hours and 24 hours later regaining consciousness. Method of measurement: Visual Analog Scale. Measurement of gut microbiome. Timepoint: Start and end of the study. Method of measurement: gut microbiome genome sequencing technique. Shahid Beheshti University of Medical Sciences Approved 2021-06-07 Ethics committee of Beheshti University of Medical Sciences Velenjak Tehran Tehran Iran (Islamic Republic of)