Investigating the effect of probiotic supplementation on clinical manifestations and laboratory findings and the treatment process of patients with Brucellosis: A triple-blind randomized controlled trial

Investigating the effect of probiotic supplementation on clinical manifestations and laboratory findings and the treatment process of patients with Brucellosis

Clinical trial with control group, with parallel and equal groups, Triple blind, randomized by the website "random.org", on 100 patients.

Patients referring to the educational-therapeutic centers of Arak city, who are diagnosed with acute brucellosis based on clinical manifestations, epidemiological factors and serological tests, and who meet other inclusion criteria, are included in the trial after obtaining informed consent. These patients are placed in one of the intervention or control groups based on randomization, and according to the group in which the patient is placed, 60 probiotic or placebo capsules placed in similar cans are delivered to them, which will be used 1 capsule daily for 60 days.

New patients with brucellosis between 18 and 65 years of age and no current pregnancy or immunodeficiency, Absence of focal, complicated or chronic forms of brucellosis and the absence of concomitant diseases

In this trial, patients in the intervention group received one probiotic capsule daily from the day of treatment for 60 days, and patients in the control group received one placebo capsule daily during this period. Both groups are under antibiotic treatment of the disease, which is used similarly for both groups.

The duration of fever, chills, musculoskeletal pain, anorexia, nausea, esophagitis, diarrhea and weakness of the patient, which is asked by phone call to the patient every day from the first day of treatment until the symptoms are resolved, and recorded in the patient's checklist. Wright and Coombs-Wright, 2ME, ESR and CRP titer, which are measured at the beginning and 60 days after the start of the study.

In this study, for the random distribution of the samples between the intervention and control groups, the web-based randomization method is used, and based on the size of the study sample, two groups with equal numbers of numbers are generated, after sorting the numbers of each group from small to Large, the groups are called group A and group B, and one group is randomly assigned to the intervention group and the other one to the control group. During the sampling, new patients with Brucellosis who meet the inclusion criteria are numbered in the order of entry and based on the mentioned grouping, each patient is randomly placed in group A or B.

In this study, the researchers, the study participants and the analyst are not aware of the random allocation method until the completion of the statistical analysis. Before the start of sampling, the process of randomization is carried out by the secretary of the infectious disease clinic using the aforementioned method to randomly assign the samples in two groups A and B, as well as packaging the drugs in similar cans and numbering them. Due to the placement of drugs in similar cans and only put the patient's number on the cans, the patients in both intervention and control groups as well as the researchers are unaware of the contents of the cans, which contain probiotic capsules or placebo. Also, the data is delivered to the analyzer in the form of two groups A and B, and the analyzer is not aware of the intervention and control groups.