The Sublimated Mare Milk Supplement in Hepatitis C

NCT03669835 | Completed

• 1 other identifier: KazNMU.MM.HC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis C

Keywords

Hepatitis C; Mare milk; Liver function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Changes in gut microbiota composition.

  Baseline, 2 weeks, 4 weeks, 8 weeks

• Intestinal immune status changes.

  Baseline, 2 weeks, 4 weeks, 8 weeks

• Changes in phospholipids spectrum of lymphocyte membranes.

  Baseline, 2 weeks, 4 weeks, 8 weeks

• Changes in degree of liver fibrosis.

  Baseline, 2 weeks, 4 weeks, 8 weeks

Study Arms (2)

Dietary supplement and standard therapy.

EXPERIMENTAL

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; Drug: Standard therapy

Standard therapy only.

OTHER

Patients would be given standard treatment for 1 month.

Drug: Standard therapy

Interventions

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.

Dietary supplement and standard therapy.

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.

Dietary supplement and standard therapy.; Standard therapy only.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asfendiyarov Kazakh National Medical University: lead
• Eurasia Invest Ltd.: collaborator
• Ministry of Education and Science, Republic of Kazakhstan: collaborator

Study Sites (1)

Asfendiyarov Kazakh National Medical University

Almaty, 050000, Kazakhstan

Location

Related Publications (6)

• Yershova IB. Features of intestinal micro-biocenosis in viral hepatitis and possibilities of its correction. Actual Infectology 2(3): 7-11, 2014

  BACKGROUND

• Mazmanian SK, Round JL, Kasper DL. A microbial symbiosis factor prevents intestinal inflammatory disease. Nature. 2008 May 29;453(7195):620-5. doi: 10.1038/nature07008.

  PMID: 18509436 BACKGROUND

• Minemura M, Shimizu Y. Gut microbiota and liver diseases. World J Gastroenterol. 2015 Feb 14;21(6):1691-702. doi: 10.3748/wjg.v21.i6.1691.

  PMID: 25684933 BACKGROUND

• Roderburg C, Luedde T. The role of the gut microbiome in the development and progression of liver cirrhosis and hepatocellular carcinoma. Gut Microbes. 2014 Jul 1;5(4):441-5. doi: 10.4161/gmic.29599. Epub 2014 Jul 9.

  PMID: 25006881 BACKGROUND

• Schnabl B. Linking intestinal homeostasis and liver disease. Curr Opin Gastroenterol. 2013 May;29(3):264-70. doi: 10.1097/MOG.0b013e32835ff948.

  PMID: 23493073 BACKGROUND

• Galina V. Fedotovskikh, Galija M. Shaymardanova, Manarbek B. Askarov, Maiya S.Zhumabaeva, Gulmira S. Dosataeva, Aigerim K. Smagulova, Sapargul Marat, Tatyana G. Ezhelenko. Efficiency of mesenchymal stem cell therapy in ulcerative colitis as assessed by the morphology of colon mucosa. J.Cellular Therapy and Transplantation.Vol.8,№2,2019,58-62.

  RESULT

MeSH Terms

Conditions

Hepatitis C

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 13, 2018
• Study Start: March 28, 2018
• Primary Completion: September 20, 2019
• Study Completion: December 1, 2020
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)