The effect of probiotic supplementation on gut microbiome composition and postoperative pain in patients undergoing open heart surgery

The effect of probiotic supplementation on intestinal microbiome composition and postoperative pain in patients undergoing open heart surgery

Clinical trial with control group, double-blind, randomized, on 100 patients

In the hospital of Shahid Beheshti University of Medical Sciences. 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.

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 gut microbiome

Patients are divided into one of two groups receiving probiotic supplement (1 g daily) and the control group (placebo receiving group). This amount of supplement is considered in the form of 2 tablets of 500 mg daily.

Pain after open heart surgery,age

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.

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.

All data is potentially shareable after unidentified individuals

Access period starts 3 months after the results are published

Researchers working in academic and scientific institutions

Obtain permission and retain the original source name

shadnoush@sbmu.ac.ir

Email to the corresponding author