INVESTIGATION of the EFFICACY and SAFETY of the DRUG "AS-PROBIONORM" with the PARTICIPATION of PATIENTS with DYSBIOSIS (phase 2)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Safety 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 second phase of a clinical trial is the study of a medicine conducted on volunteers to establish efficacy and safety.
According to this study, the aim of this clinical trial is to investigate the efficacy, safety, and optimal dosage regimen for the investigational medicinal product AS-Probionorm (powder in sachets of 1 gram) for oral administration in patients with dysbiosis.
Phase II of the clinical trial of the medicine included 210 study subjects with identified clinical and/or microbiological signs of dysbiosis. 3 groups of 70 research subjects will be formed.
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 II of clinical trial. Dosage regimen for first group - 1 sachet (1 g) 2 times a day (morning and evening) 15 min prior food , with an interval of 12 hours. The total duration of study subjects' participation in the study is 28 days. Dosage regimen for the second and third groups - 2 sachet (2 g) 2 times a day (morning and evening) 15 min prior food , with an interval of 12 hours. The total duration of study subjects' participation in the study is 28 days.
Safety of the study drug: The safety assessment of AS-Probinorm (powder in sachets) is based on the results of dynamic monitoring of study subjects after they take the study drug for one day and for the next 42 days. The following data are used as the basis for the assessment: complaints, physical examination results, and results of laboratory and instrumental research methods.
The effectiveness of the drug will be evaluated based on the subjective experiences and sensations reported by patients, as well as objective data collected by the researchers during the study.
The degree of effectiveness of the studied drug will be assessed based on three categories:
- Intolerance - the appearance of local symptoms of allergy/pseudoallergy and systemic symptoms such as tachycardia (heart rate greater than 90 beats per minute for more than 30 minutes after administration), lowered blood pressure (lower than 100/60 mm Hg within 30 minutes of application), and serious adverse reactions.
- No adverse reactions
- Undesirable effects that are not considered 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 for patients with dysbiosis.
Pharmacological group - Antidiarrheal drugs. Antidiarrheal microorganisms. Microorganisms that produce lactic acid.
Introduction:
Acute intestinal infections (AKI) are a significant health problem in all countries, including Kazakhstan. Due to their widespread prevalence, high incidence of moderate and severe forms, and potential complications, it is essential to find ways to improve treatment strategies for this group of illnesses.
Probiotics based on beneficial microorganisms from the gastrointestinal tract are increasingly being recommended for the treatment of intestinal and urinary tract infections instead of antibiotics worldwide. Lactic acid bacteria and bifidobacteria are among the most commonly used, as experts consider their pathogenic potential to be sufficiently low for oral administration at conventional doses. These medications quickly suppress harmful microbes and activate the immune system. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
入选标准
- •Patients with dysbiosis - Bacterial overgrowth syndrome (ICD-10 PK K63.8 Other specified intestinal diseases) of both sexes aged 18-50 years
- •Patients with Irritable Bowel Syndrome (ICD-10 RC K58)
- •Patients with Irritable bowel syndrome with diarrhea (ICD-10 RC K58.0)
- •Patients with Irritable bowel syndrome without diarrhea (ICD-10 RC K58.9)
- •Patients with verified health status, absence of chronic and acute systemic diseases and intestinal;
- •For women, a negative pregnancy test and consent to adhere to adequate methods of contraception.
- •A voluntary desire to participate in the study.
排除标准
- •Subjects with a history of allergy to milk, and during screening (drug, pollen, and other types), individual hypersensitivity to the components of the drug;
- •Subjects with chronic diseases (tuberculosis, hepatitis, HIV infection, diabetes mellitus, cancer, blood diseases), chronic renal failure, chronic liver failure, exacerbations of chronic diseases;
- •Subjects who participate in parallel clinical trials of other medicines, or who have participated in them for 3 months. from the beginning of the current study;
- •Subjects planning to participate in the research should not take any other medications for 2 weeks before the clinical trials of the test drug.;
- •Subjects from the category of "vulnerable" (homeless, military personnel, the incapacitated, patients in urgent conditions, other persons who may be under pressure);
- •Pregnancy and breast - feeding;
- •The subject of the study does not agree to perform the procedures required by the protocol and is unable to adhere to the schedule of procedures.
研究组 & 干预措施
Subjects with identified clinical and/or microbiological signs of dysbiosis
Dosage regimen for first group - 1 sachet (1 g) 2 times a day (morning and evening) 15 min prior food , with an interval of 12 hours. The total duration of study subjects' participation in the study is 28 days. Dosage regimen for the second and third groups - 2 sachet (2 g) 2 times a day (morning and evening) 15 min prior food , with an interval of 12 hours. The total duration of study subjects' participation in the study is 28 days.
干预措施: "AS-Probionorm" (Drug)
结局指标
主要结局
Safety of the study drug:
时间窗: 1 day of taking the drug for the next 42 days
Safety of the study drug: The safety assessment of AS-Probinorm (powder in sachets) is based on the results of dynamic monitoring of study subjects after they take the study drug for one day and for the next 42 days. The following data are used as the basis for the assessment: complaints, physical examination results, and results of laboratory and instrumental research methods. Safety assessment criteria: absence of dysbiotic disorders, absence of allergic manifestations, absence of clinically significant changes in the blood formula, determination of the level of aminotransferases (ALT, AST), serum albumin, sugar, blood bilirubin, reactions from the gastrointestinal tract, general somatic state (body temperature, blood pressure, heart rate) of the study subjects during research. Absence of undesirable reactions. At the recommended doses, the investigational drug does not cause a negative reaction of the body.
The effectiveness of the drug
时间窗: During 24 hours
The effectiveness of the drug will be evaluated based on the subjective experiences and sensations reported by patients, as well as objective data collected by the researchers during the study. The degree of effectiveness of the studied drug will be assessed based on three categories: * Intolerance - the appearance of local symptoms of allergy/pseudoallergy and systemic symptoms such as tachycardia (heart rate greater than 90 beats per minute for more than 30 minutes after administration), lowered blood pressure (lower than 100/60 mm Hg within 30 minutes of application), and serious adverse reactions. * No adverse reactions * Undesirable effects that are not considered serious
次要结局
未报告次要终点