The Sublimated Mare Milk Supplement in Hepatitis C

February 3, 2021 updated by: Yermekbayeva Bakytgul, Asfendiyarov Kazakh National Medical University

The Sublimated Mare Milk Supplement In Patients With Hepatitis C

This clinical trial studies the effect of sublimated mare milk supplement on patients with hepatitis C.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic viral hepatitis C is one of the medical, social and economic public health problems throughout the world. In majority of patients with chronic viral hepatitis C, dysbiotic changes are detected in the intestinal tract. Disturbances of microbial equilibrium are associated with the degree of inflammation, morphological changes in the liver, nature of the course and the stage of the disease.

These dysbiotic changes and and associated immune disorders can significantly aggravate the course of immune processes in the liver, converting hepatitis C infection to a chronic disease.

Mare milk is frequently reported for having therapeutic and dietary properties, which are initially associated with a specific chemical composition and certain physical properties of the product. It contains a total of about 40 biologically active components, the most important of them vitamins A, C, B1, B2, B6, B12, amino acids, enzymes and trace elements, there are low molecular weight peptides, lactalbumins and globulins.

The use of mare milk can contribute to the restoration of impaired functions of damaged organs and tissues, and play the role of an auxiliary pathogenetic therapy, primarily in certain chronic diseases of the digestive system, including chronic viral hepatitis C. Mare milk can also be used as a powder supplement through sublimation process.

In this trial, the effect of this supplement consisting of sublimated mare milk on hepatitis C patients will be evaluated. There will be two parallel groups: Interventional (sublimated mare milk supplement with standard treatment) and Standard treatment group. Differences in laboratory characteristics will be quantitively analyzed between groups.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan, 050000
        • Asfendiyarov Kazakh National Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with verified diagnosis of hepatitis C
  • Aged 18 to 65 years
  • Normal intestinal microbiota composition (anaerobes-95%, aerobes-5%)
  • Normal level of immune system markers in blood (Immunoglobulin M and Immunoglobulin G)
  • Decreased levels of phosphatidylethanolamine, phosphatidylserine, phosphatidylcholine, sphingomyelin
  • Elevated lysophosphatidylcholine
  • Willingness to consent to participate in the study
  • Consent to adhere to treatment

Exclusion Criteria:

  • Drug and/or alcohol dependence
  • Allergy to dairy products
  • People with mental disabilities and/or life-threatening conditions
  • Pregnancy and/or lactation
  • Lactose intolerance
  • Refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dietary supplement and standard therapy.
Participants will take a supplement of 1 sachet (20 mg) 3 times/day accompanied with the standard therapy for 1 month.
Dietary supplement: Mare milk supplement
Supplement consisting of sublimated mare's milk with single-dose 20 mg sachet. The supplement is dissolved in 36-27 degrees of Celsius water and taken 15-20 minutes before meal.
Drug: Standard therapy
For hepatitis virus C genotype 1: sofosbuvir 400 mg + lepidavir 90 mg for 12 weeks OR sofosbuvir 400 mg + daclatasvir 60 mg for 12 weeks; For hepatitis virus C genotypes 2 and 3: sofosbuvir 400 mg + daclatasvir 60 mg for 12 weeks.
OTHER: Standard therapy only.
Patients would be given standard treatment for 1 month.
Drug: Standard therapy
For hepatitis virus C genotype 1: sofosbuvir 400 mg + lepidavir 90 mg for 12 weeks OR sofosbuvir 400 mg + daclatasvir 60 mg for 12 weeks; For hepatitis virus C genotypes 2 and 3: sofosbuvir 400 mg + daclatasvir 60 mg for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in liver function.
Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Change in liver function will be assessed from biochemical blood results of alanine transaminase and aspartate transaminase.
Baseline, 2 weeks, 4 weeks, 8 weeks
Change in urine test.
Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Proportion of patients with deviations from normal range of urine test.
Baseline, 2 weeks, 4 weeks, 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in gut microbiota composition.
Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Proportions of aerobic and anaerobic bacteria will be assessed from stool samples using MiSeq Sequencing System.
Baseline, 2 weeks, 4 weeks, 8 weeks
Intestinal immune status changes.
Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Level of immune status markers (Immunoglobulin G, Immunoglobulin M) will be detected from blood samples.
Baseline, 2 weeks, 4 weeks, 8 weeks
Changes in phospholipids spectrum of lymphocyte membranes.
Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Detection of changes in phospholipids spectrum of lymphocyte membranes (phosphatidylethanolamine, phosphatidylserine, phosphatidylcholine, sphingomyelin, lysophosphatidylcholine) will be performed using the thin-layer chromatography method.
Baseline, 2 weeks, 4 weeks, 8 weeks
Changes in degree of liver fibrosis.
Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Liver fibrosis will be evaluated using transient elastography method.
Baseline, 2 weeks, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asfendiyarov Kazakh National Medical University

Collaborators

Eurasia Invest Ltd.
Ministry of Education and Science, Republic of Kazakhstan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 28, 2018

Primary Completion (ACTUAL)

September 20, 2019

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (ACTUAL)

September 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KazNMU.MM.HC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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