The Sublimated Mare Milk Supplement in Hepatitis C

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

Detailed Description
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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.

Official Title
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The Sublimated Mare Milk Supplement In Patients With Hepatitis C

Conditions
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Hepatitis C

Intervention / Treatment
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* Dietary Supplement: Mare milk supplement
* Drug: Standard therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement and standard therapy.<br>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<br>* 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.<br>Drug: Standard therapy<br>* 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.<br>|
| Other: Standard therapy only.<br>Patients would be given standard treatment for 1 month. | Drug: Standard therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver function. | 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. | 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. | 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. | 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. | 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. | Liver fibrosis will be evaluated using transient elastography method. | Baseline, 2 weeks, 4 weeks, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver function, Hepatitis C, Mare milk