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IRCT20240130060856N1 IRCT 2024-02-13 Arak University of Medical Sciences Investigating the effect of probiotic supplementation on Brucellosis 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 2024-02-20 anticipated 100 Complete https://irct.ir/trial/75252 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Brucellosis. Intervention 1: Intervention group: Daily taking of one Lactocare probiotic capsule containing 10^9 CFU of bacteria for 60 days. Intervention 2: Control group: Daily taking of one placebo capsule containing wheat starch for 60 days. 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 There is no further information
public Seyyed Amirhossein Mousavi
Arak University of Medical Siences, Basij Sq., Arak, Iran
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3502 mosavia7777@gmail.com Arak University of Medical Sciences scientific Dr. Hossein Mazaherpour
Arak University of Medical Siences, Basij Sq., Arak, Iran
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3502 h.mazaherpour@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Patients with new onset Brucellosis 18 years 65 years Both Presence of immunodeficiency in the patient Taking immunosuppressive drugs Presence of concomitant diseases such as tuberculosis, malignancy, liver cirrhosis and ESRD Current pregnancy Presence of focal, complicated or chronic forms of Brucellosis A23 Brucellosis Treatment - Drugs Placebo Intervention group: Daily taking of one Lactocare probiotic capsule containing 10^9 CFU of bacteria for 60 days Control group: Daily taking of one placebo capsule containing wheat starch for 60 days Duration of fever. Timepoint: Daily from the beginning of the intervention until the symptom disappears. Method of measurement: Patient checklist. Duration of chills. Timepoint: Daily from the beginning of the intervention until the symptom disappears. Method of measurement: Patient checklist. Duration of musculoskeletal pain. Timepoint: Daily from the beginning of the intervention until the symptom disappears. Method of measurement: Patient checklist. Duration of anorexia. Timepoint: Daily from the beginning of the intervention until the symptom disappears. Method of measurement: Patient checklist. Duration of weakness. Timepoint: Daily from the beginning of the intervention until the symptom disappears. Method of measurement: Patient checklist. Duration of diarrhea. Timepoint: Daily from the beginning of the intervention until the symptom disappears. Method of measurement: Patient checklist. Duration of nausea. Timepoint: Daily from the beginning of the intervention until the symptom disappears. Method of measurement: Patient checklist. Duration of esophagitis. Timepoint: Daily from the beginning of the intervention until the symptom disappears. Method of measurement: Patient checklist. Wright. Timepoint: At baseline and 60 days after the initiation of trial. Method of measurement: Laboratory kit. Coombs Wright. Timepoint: At baseline and 60 days after the initiation of trial. Method of measurement: Laboratory kit. ESR. Timepoint: At baseline and 60 days after the initiation of trial. Method of measurement: Laboratory kit. CRP. Timepoint: At baseline and 60 days after the initiation of trial. Method of measurement: Laboratory kit. 2ME. Timepoint: At baseline and 60 days after the initiation of trial. Method of measurement: Laboratory kit. Arak University of Medical Sciences Approved 2024-01-07 Ethics committee of Arak University of Medical Sciences Arak University of Medical Siences, Basij Sq., Arak, Iran Arak Markazi Iran (Islamic Republic of)