Clinical trial NCT03669835: The Sublimated Mare Milk Supplement in Hepatitis C
Official title: The Sublimated Mare Milk Supplement In Patients With Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: Hepatitis C
Mare milk
Liver function
Lead sponsor: Asfendiyarov Kazakh National Medical University
Sponsor class: OTHER
Collaborators: name: Eurasia Invest Ltd.
name: Ministry of Education and Science, Republic of Kazakhstan
First posted: 2018-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Change in liver function.
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks
measure: Change in urine test.
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks
Secondary outcomes:
measure: Changes in gut microbiota composition.
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks
measure: Intestinal immune status changes.
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks
measure: Changes in phospholipids spectrum of lymphocyte membranes.
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks
measure: Changes in degree of liver fibrosis.
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Asfendiyarov Kazakh National Medical University
Study officials:
References:
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