Status:
COMPLETED
INVESTIGATION of the EFFICACY and SAFETY of the DRUG "AS-PROBIONORM"
Lead Sponsor:
Industrial Microbiology LLP
Conditions:
Intestinal Infections
Dysbacteriosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The subject of this clinical trial is the medicine "AS-Probionorm". Pharmacological group - Antidiarrheal drugs. Antidiarrheal microorganisms. Microorganisms that produce lactic acid. The investigati...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2024
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06886399
Start Date
July 22 2024
End Date
August 11 2024
Last Update
March 20 2025
Active Locations (1)
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1
MIPO Clinic LLP
Almaty, Kazakhstan