Hepatitis CNCT03669835
The Sublimated Mare Milk Supplement in Hepatitis C
A study testing Mare milk supplement and Standard therapy in people with Hepatitis C, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.
Trial summary
This clinical trial studies the effect of sublimated mare milk supplement on patients with hepatitis C. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Mare milk supplement and Standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteKazakhstan
- Study dates
- 28 Mar 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
Asfendiyarov Kazakh National Medical University
Almaty, 050000
About this study
Official title: The Sublimated Mare Milk Supplement In Patients With Hepatitis C
This clinical trial studies the effect of sublimated mare milk supplement on patients with hepatitis C.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Mare milk supplement, Standard therapy
- Keywords
- Hepatitis C, Mare milk, Liver function
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mare milk supplementDietary 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 therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Mare milk supplement; Drug: Standard therapy |
| Standard therapy only. | Other | Patients would be given standard treatment for 1 month. Receives: Drug: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver function.
Change in liver function will be assessed from biochemical blood results of alanine transaminase and aspartate transaminase.
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks
Change in urine test.
Proportion of patients with deviations from normal range of urine test.
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks
Secondary outcomes (4)
Changes in gut microbiota composition.
Proportions of aerobic and anaerobic bacteria will be assessed from stool samples using MiSeq Sequencing System.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks
Changes in degree of liver fibrosis.
Liver fibrosis will be evaluated using transient elastography method.
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start28 Mar 2018
- Primary completion20 Sep 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asfendiyarov Kazakh National Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Eurasia Invest Ltd., Ministry of Education and Science, Republic of Kazakhstan
- Responsible party
- Principal investigator, Yermekbayeva Bakytgul, Asfendiyarov Kazakh National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669835
- Sponsor's protocol ID
- KazNMU.MM.HC
- Status last verified
- Feb 2021
- First submitted
- 6 Sep 2018
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yershova IB. Features of intestinal micro-biocenosis in viral hepatitis and possibilities of its correction. Actual Infectology 2(3): 7-11, 2014
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.
PubMed 18509436Minemura 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.
PubMed 25684933Roderburg 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.
PubMed 25006881Schnabl B. Linking intestinal homeostasis and liver disease. Curr Opin Gastroenterol. 2013 May;29(3):264-70. doi: 10.1097/MOG.0b013e32835ff948.
PubMed 23493073Galina 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sublimated Mare Milk Supplement In Patients With Hepatitis C
- ClinicalTrials.gov ID
- NCT03669835
- Acronym / sponsor ID
- KazNMU.MM.HC
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Mare milk, Liver function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Asfendiyarov Kazakh National Medical UniversityUniversity, hospital or other
- Collaborators
- Eurasia Invest Ltd., Ministry of Education and Science, Republic of Kazakhstan
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement and standard therapy. | Experimental | Dietary Supplement: Mare milk supplement, Drug: Standard therapyParticipants will take a supplement of 1 sachet (20 mg) 3 times/day accompanied with the standard therapy for 1 month. |
| Standard therapy only. | Other | Drug: Standard therapyPatients would be given standard treatment for 1 month. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- Drug and/or alcohol dependence
- Allergy to dairy products
- People with mental disabilities and/or life-threatening conditions
- Pregnancy and/or lactation
- Lactose intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mare milk supplementSupplement 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 | Dietary supplement and standard therapy. |
| Standard therapyFor 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. | Drug | Dietary supplement and standard therapy., Standard therapy only. |
Primary outcome
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.
Change in urine test.
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Proportion of patients with deviations from normal range of urine test.
4 secondary outcomes
Changes in gut microbiota composition.
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Intestinal immune status changes.
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Changes in phospholipids spectrum of lymphocyte membranes.
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Changes in degree of liver fibrosis.
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- BackgroundYershova IB. Features of intestinal micro-biocenosis in viral hepatitis and possibilities of its correction. Actual Infectology 2(3): 7-11, 2014
- Background: PubMed 18509436Mazmanian 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.
- Background: PubMed 25684933Minemura 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.
- Background: PubMed 25006881Roderburg 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.
- Background: PubMed 23493073Schnabl B. Linking intestinal homeostasis and liver disease. Curr Opin Gastroenterol. 2013 May;29(3):264-70. doi: 10.1097/MOG.0b013e32835ff948.
- Results publicationGalina 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mare milk supplement and Standard therapy in people with Hepatitis C, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver function. (time frame: Baseline, 2 weeks, 4 weeks, 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03669835, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.