Study of the Safety and Tolerability of the Broad-spectrum Probiotic Medicine "AS-Probionorm" Against Human Intestinal Infections in Healthy Volunteers Produced by Industrial Microbiology LLP (Phase 1)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tolerability of the study drug
研究概览
简要总结
The subject of this clinical trial is the medicine "AS-Probionorm". Pharmacological group - Antidiarrheal drugs. Antidiarrheal microorganisms. Microorganisms that produce lactic acid.
The investigational probiotic medicine "AS-Probionorm" was created on the basis of an association of lactic acid bacteria with targeted action for oral use for the treatment of inflammatory and infectious diseases of the human gastrointestinal tract.
The first phase of a clinical trial is the first test of a medicine conducted on healthy volunteers to establish tolerability and safety.
According to the goal and objectives of the phase I clinical trial, the main parameter is to study the safety and tolerability of the medicine throughout the entire study period.
Phase I of the clinical trial of the medicine included 20 healthy subjects of both sexes aged 18-50 years. Clinical and laboratory parameters to characterize the safety of the medicine: medical history, physical examination, ECG, general and biochemical blood tests, urine and stool tests.
Selection and Exclusion of Subjects: Prior to inclusion in a clinical trial, each trial subject must first sign an Informed Consent Form for Participation in the Study, followed by a screening examination of each subject, including a variety of procedures, medical history, and physical examination. Each subject participating in the survey will be assigned an identification number.
Study design: open-label, single-center, phase I of clinical trial. Dosage regimen - 1 sachet (1 g) 2 times a day with an interval of 12 hours. The total duration of study subjects' participation in the study is 21 days. Tolerability of the study drug: Tolerability of the drug will be assessed based on subjective symptoms and sensations reported by patients and objective data obtained by the investigator during the study. The frequency of occurrence and nature of adverse reactions are also taken into account.
The degree of tolerability of the study drug will be determined in three gradations: intolerance, absence of undesirable drug reactions (side reactions), undesirable drug reactions (side effects) not classified as serious.
Ethical and Legal Issues in Clinical Research: This clinical trial will be conducted in accordance with the principles set forth by the 18th World Medical Assembly (Helsinki, 1964) and the ICH guidelines for good clinical practice (GCP), and in accordance with all international and national laws and regulations.
详细描述
Dosage form of the medicine "AS-Probionorm" (powder for the preparation of solution for oral administration) - 1 g in a sachet.
Pharmacological group - Antidiarrheal drugs. Antidiarrheal microorganisms. Microorganisms that produce lactic acid.
Introduction:
Acute intestinal infections (AII) are one of the pressing health problems in all countries. The complexity of their treatment is associated with the massive irrational use of antibiotics and chemotherapeutic drugs, which has led to the development of multidrug resistance in pathogens. Therefore, the modern strategy for the treatment of acute intestinal infections gives priority to therapeutic measures aimed at correcting intestinal microbiocenosis to eliminate the source of infection localized in the intestine.
The main idea is to conduct clinical studies of the domestic medicinal probiotic medicine "AS-Probionorm" based on the association of lactic acid bacteria of targeted action for oral use for the treatment of inflammatory and infectious diseases of the human gastrointestinal tract.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers of both sexes aged 18-50 years with a verified state of health, absence of chronic and acute systemic and intestinal diseases; for women - a negative pregnancy test and agreement to adhere to adequate methods of contraception.
- •Voluntary desire to participate in the study.
排除标准
- •Persons with a history of allergies to milk, and during screening (drug, pollen and other types), individual hypersensitivity to the components of the drug;
- •Persons with chronic diseases (tuberculosis, hepatitis, HIV infection, diabetes mellitus, cancer, blood diseases), chronic renal failure, chronic liver failure, exacerbations of chronic diseases;
- •Persons taking parallel participation in clinical trials of other drugs or participating in them for 3 months from the start of the current study;
- •Persons planning to participate in studies should not take any other medications for 2 weeks before clinical studies of the test drug;
- •Persons from the category of "vulnerable patients" (homeless, military personnel, incapacitated, patients in emergency conditions, other persons who may be under pressure);
- •Pregnancy and breastfeeding;
- •The research subject does not agree to perform the procedures required by the protocol and is unable to adhere to the procedure schedule.
研究组 & 干预措施
Healthy volunteers
1 sachet (1 g) take 2 times a day with an interval of 12 hours. The duration of taking the medicine is 7 days. The study is carried out on an outpatient basis. The total duration of each subject's participation in the clinical trial is no more than 21±1 days.
干预措施: "AS-Probionorm" (Drug)
结局指标
主要结局
Tolerability of the study drug
时间窗: 21 days
The degree of tolerability of the study drug will be determined in three gradations: * Intolerance - the appearance of local signs of allergy/pseudoallergy and systemic signs - tachycardia (heart rate more than 90 per minute within 30 minutes after administration), decreased blood pressure (less than 100/60 mmHg within 30 minutes after application), serious adverse drug reactions. * Absence of unwanted drug reactions (side reactions). * Adverse drug reactions (side effects) that are not classified as serious.
Safety assessment criteria
时间窗: 21 days
Absence of clinically significant changes in the parameters of general blood and urine tests, biochemical blood tests, and microbiological studies of stool of the study subjects during the study period.
次要结局
未报告次要终点