Skip to main content
OpenTrials
Completed

NCT Number: NCT03669835

The Sublimated Mare Milk Supplement in Hepatitis C

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asfendiyarov Kazakh National Medical University

Almaty, 050000, Kazakhstan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mare milk supplement

Dietary 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.

Standard therapy

Drug

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.

Primary outcomes

  1. 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.

  2. Change in urine test.

    Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks

    Proportion of patients with deviations from normal range of urine test.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Changes in degree of liver fibrosis.

    Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks

    Liver fibrosis will be evaluated using transient elastography method.

Sponsors and collaborators

Lead sponsor

Asfendiyarov Kazakh National Medical University

Other

Collaborators

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

Registry information

Official study title

The Sublimated Mare Milk Supplement In Patients With Hepatitis C

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 13, 2018
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.