INVESTIGATION of the EFFICACY and SAFETY of the DRUG "AS-PROBIONORM"

Summary

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.

Conditions

• Intestinal Infections
• Dysbacteriosis

Interventions

DRUG

"AS-Probionorm"

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. Group 1 - study subjects with an identified decrease in intestinal microflora activity; Group 2 - study subjects with an identified fungal (candidiasis) infection; Group 3 - study subjects with active pathogenic microflora. 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.

Sponsors & Collaborators

• Industrial Microbiology LLP

  lead OTHER

Principal Investigators

• Ilyas Kulmagambetov, Doctor of Med. Sc. · Centre for Clinical Medicine and Research LLP

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-22

Primary Completion

2024-08-11

Completion

2024-08-11

Countries

• Kazakhstan

Study Locations