Study of the Safety and Tolerability of the Broad-spectrum Probiotic Medicine "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 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.

Conditions

• Intestinal Infections
• Dysbacteriosis

Interventions

DRUG

"AS-Probionorm"

Dosage form - powder for the preparation of a solution for oral administration. Dosage regimen -1 sachet (1 g) take 2 times a day with an interval of 12 hours. Apply 15-20 minutes before meals in the morning and evening. Before use, the medicine is mixed with 30-50 ml of boiled water at room temperature, resulting in a cream-colored suspension. The resulting aqueous suspension should be drunk without achieving complete dissolution. The diluted drug cannot be stored. 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. Throughout the entire study period, the research subject has the opportunity to contact the research team on all questions relating to the nature of this study. After completion of the entire observation period of 21 days, there is no follow-up of study subjects under the trial protocol.

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

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-02

Primary Completion

2023-10-14

Completion

2023-10-14

Countries

• Kazakhstan

Study Locations