Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT03669835
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2018-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Sublimated Mare Milk Supplement in Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-11', 'lastUpdatePostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in liver function.', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 8 weeks', 'description': 'Change in liver function will be assessed from biochemical blood results of alanine transaminase and aspartate transaminase.'}, {'measure': 'Change in urine test.', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 8 weeks', 'description': 'Proportion of patients with deviations from normal range of urine test.'}], 'secondaryOutcomes': [{'measure': 'Changes in gut microbiota composition.', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 8 weeks', 'description': 'Proportions of aerobic and anaerobic bacteria will be assessed from stool samples using MiSeq Sequencing System.'}, {'measure': 'Intestinal immune status changes.', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 8 weeks', 'description': 'Level of immune status markers (Immunoglobulin G, Immunoglobulin M) will be detected from blood samples.'}, {'measure': 'Changes in phospholipids spectrum of lymphocyte membranes.', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 8 weeks', 'description': 'Detection of changes in phospholipids spectrum of lymphocyte membranes (phosphatidylethanolamine, phosphatidylserine, phosphatidylcholine, sphingomyelin, lysophosphatidylcholine) will be performed using the thin-layer chromatography method.'}, {'measure': 'Changes in degree of liver fibrosis.', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 8 weeks', 'description': 'Liver fibrosis will be evaluated using transient elastography method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis C', 'Mare milk', 'Liver function'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Yershova IB. Features of intestinal micro-biocenosis in viral hepatitis and possibilities of its correction. Actual Infectology 2(3): 7-11, 2014'}, {'pmid': '18509436', 'type': 'BACKGROUND', 'citation': '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': '25684933', 'type': 'BACKGROUND', 'citation': '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': '25006881', 'type': 'BACKGROUND', 'citation': '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': '23493073', 'type': 'BACKGROUND', 'citation': 'Schnabl B. Linking intestinal homeostasis and liver disease. Curr Opin Gastroenterol. 2013 May;29(3):264-70. doi: 10.1097/MOG.0b013e32835ff948.'}, {'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial studies the effect of sublimated mare milk supplement on patients with hepatitis C.', 'detailedDescription': '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.\n\nThese 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.\n\nMare 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.\n\nThe 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with verified diagnosis of hepatitis C\n* Aged 18 to 65 years\n* Normal intestinal microbiota composition (anaerobes-95%, aerobes-5%)\n* Normal level of immune system markers in blood (Immunoglobulin M and Immunoglobulin G)\n* Decreased levels of phosphatidylethanolamine, phosphatidylserine, phosphatidylcholine, sphingomyelin\n* Elevated lysophosphatidylcholine\n* Willingness to consent to participate in the study\n* Consent to adhere to treatment\n\nExclusion Criteria:\n\n* Drug and/or alcohol dependence\n* Allergy to dairy products\n* People with mental disabilities and/or life-threatening conditions\n* Pregnancy and/or lactation\n* Lactose intolerance\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT03669835', 'briefTitle': 'The Sublimated Mare Milk Supplement in Hepatitis C', 'organization': {'class': 'OTHER', 'fullName': 'Asfendiyarov Kazakh National Medical University'}, 'officialTitle': 'The Sublimated Mare Milk Supplement In Patients With Hepatitis C', 'orgStudyIdInfo': {'id': 'KazNMU.MM.HC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietary supplement and standard therapy.', 'description': 'Participants will take a supplement of 1 sachet (20 mg) 3 times/day accompanied with the standard therapy for 1 month.', 'interventionNames': ['Dietary Supplement: Mare milk supplement', 'Drug: Standard therapy']}, {'type': 'OTHER', 'label': 'Standard therapy only.', 'description': 'Patients would be given standard treatment for 1 month.', 'interventionNames': ['Drug: Standard therapy']}], 'interventions': [{'name': 'Mare milk supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': "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.", 'armGroupLabels': ['Dietary supplement and standard therapy.']}, {'name': 'Standard therapy', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Dietary supplement and standard therapy.', 'Standard therapy only.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'Asfendiyarov Kazakh National Medical University', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asfendiyarov Kazakh National Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eurasia Invest Ltd.', 'class': 'INDUSTRY'}, {'name': 'Ministry of Education and Science, Republic of Kazakhstan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD, PhD', 'investigatorFullName': 'Yermekbayeva Bakytgul', 'investigatorAffiliation': 'Asfendiyarov Kazakh National Medical University'}}}}