First Phase of the Clinical trial of the AS-Probionorm Probiotic Medication for the treatment of Human Intestinal Infections

2024

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DOI 10.52711/0974-360x.2024.00613
Data confidence 70 medium
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Abstract

The effectiveness of probiotic medications in the treatment of infectious diseases of the gastrointestinal tract has been proven in many clinical studies. Despite this, currently, some preparations do not have the appropriate quality and activity against pathogenic microorganisms. The reason for this is the lack of a stage for the selection of antagonists to specific pathogens at the stage of research and medication development. Given the high prevalence of intestinal infections among the population of Kazakhstan and the lack of made-in-Kazakhstan probiotic medications in the pharmaceutical market, there is a need to introduce an effective preparation based on probiotic microorganisms for the treatment of infectious diseases of the gastrointestinal tract. The purpose of this study was to demonstrate the methodology and results of the first phase of clinical trials of this preparation. The study was conducted following the ethical principles of the Helsinki Declaration, the Order of the Acting Minister of Health of the Republic of Kazakhstan, the Order of the Minister of Health of the Republic of Kazakhstan, and the Code of the Republic of Kazakhstan. 20 healthy volunteers of both sexes aged 18 to 50 years with a verified state of health, who had given informed consent, were examined before the start of the study, and the results of clinical measurement of the initial condition were also obtained, which was then compared with daily measurements during the use of the preparation under study and a week after the last administration. As a result of the study, it was concluded that the preparation was well-tolerated without noticeable side effects, which indicates the safety of the medication.