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The Sublimated Mare Milk Supplement in Hepatitis C

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ClinicalTrials.gov Identifier: NCT03669835
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborators:
Eurasia Invest Ltd.
Ministry of Education and Science, Republic of Kazakhstan
Information provided by (Responsible Party):
Asfendiyarov Kazakh National Medical University

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

Condition or disease Intervention/treatment Phase
Hepatitis C Dietary Supplement: Mare milk supplement Drug: Standard therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Sublimated Mare Milk Supplement In Patients With Hepatitis C
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : September 20, 2018
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669835


Contacts
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Contact: Abdugani Mussayev, MD +77772509406 musaev.dr@mail.ru
Contact: Yelena Slavko, MD +77772210319 y.slavko@kaznmu.kz

Locations
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Kazakhstan
Asfendiyarov Kazakh National Medical University Recruiting
Almaty, Kazakhstan, 050000
Contact: Abdugani Mussayev, MD, PhD    +77772509406    musaev.dr@mail.ru   
Principal Investigator: Abdugani Mussayev, MD, PhD         
Sub-Investigator: Saniya Kozhakhmetova, PhD         
Sub-Investigator: Baurzhan Zhusupov, MPH         
Sub-Investigator: Ainur Yeshmanova, PhD         
Sub-Investigator: Yelena Slavko, PhD         
Sub-Investigator: Almira Satbayeva, PhD         
Sub-Investigator: Zarina Zhanen, MD         
Sub-Investigator: Zhasulan Mergenbayev, MD         
Sub-Investigator: Akbota Myrzhashova, MD         
Sponsors and Collaborators
Asfendiyarov Kazakh National Medical University
Eurasia Invest Ltd.
Ministry of Education and Science, Republic of Kazakhstan

Publications:
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Responsible Party: Asfendiyarov Kazakh National Medical University
ClinicalTrials.gov Identifier: NCT03669835     History of Changes
Other Study ID Numbers: KazNMU.MM.HC
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Asfendiyarov Kazakh National Medical University:
Hepatitis C
Mare milk
Liver function

Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections