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Therapeutic And Dietary Effects Of The Sublimated Mare's Milk Supplement In Patients With Non-Alcoholic Steatohepatitis

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ClinicalTrials.gov Identifier: NCT03664596
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Collaborators:
Eurasia Invest Ltd.
Ministry of Education and Science, Republic of Kazakhstan
Information provided by (Responsible Party):
Medical Centre Hospital of the President’s Affairs Administration, Republic of Kazakhstan

Brief Summary:
This study evaluates the dietary and therapeutic effect of supplement consisting of sublimated mare milk among patients with non-alcoholic steatohepatitis.

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Dietary Supplement: Sublimated mare's milk Drug: Ursodeoxycholic Acid Not Applicable

Detailed Description:

Nonalcoholic steatohepatitis (NASH) is characterized by the liver damage in the form of fatty degeneration and hepatitis in people who do not abuse alcohol. The disease often develops in middle-aged women with excessive body weight, increased blood glucose and blood lipids, but can occur in all age groups and in both sexes. In most cases, the disease is asymptomatic. Laboratory data indicate an increase in the level of aminotransaminases. Ultrasound reveals hyperechoic tissue of the liver due to diffuse fatty infiltration. The degree of steatosis can also be estimated by a controlled attenuation parameter (CAP - Controlled Attenuation Parameter) in the fibroelastometry of liver tissue. It is also possible to verify the degree of fibrosis of liver tissue in its presence. Given that the mare's milk has therapeutic and dietary properties for various diseases of the internal organs, including liver diseases, the investigators decided to study its therapeutic effectiveness in NASH.

In this clinical study, the effectiveness of mare's milk in NASH will be studied in comparison with control groups taking monotherapy with ursodeoxycholic acid (UDCA) and combined therapy (mare's milk and UDCA). Patients will receive a sublimated form of mare's milk in the appropriate dosage within 2 months, and the results of clinical laboratory and instrumental studies will be compared among themselves using statistical methods.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation Of The Therapeutic And Dietary Properties Of The Sublimated Mare's Milk Supplement In Patients With Non-Alcoholic Steatohepatitis
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: Dietary supplement only
Participants will take a sublimated mare milk of 1 sachet 3 times a day during 2 months.
Dietary Supplement: Sublimated mare's milk
Supplement obtained through sublimation of mare milk, packed into one-dosage sachet (20g), and dissolved in a warm water (36 degrees of Celcius).

Dietary supplement and ursodeoxycholic acid therapy
Patients with non-alcoholic steatohepatitis will take ursodeoxycholic acid (2-3 times/day) combined with the mare's milk supplement (1 sachet, 3 times/day) for two months.
Dietary Supplement: Sublimated mare's milk
Supplement obtained through sublimation of mare milk, packed into one-dosage sachet (20g), and dissolved in a warm water (36 degrees of Celcius).

Drug: Ursodeoxycholic Acid
Ursodeoxycholic acid in the form of 250 mg capsule.

Active Comparator: Ursodeoxycholic acid therapy only
Patients with verified diagnosis of non-alcoholic steatohepatitis would be given treatment of ursodeoxycholic acid (2-3 times/day) for a two-month period.
Drug: Ursodeoxycholic Acid
Ursodeoxycholic acid in the form of 250 mg capsule.




Primary Outcome Measures :
  1. Change in liver function indicators [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]
    Blood samples will be taken to determine changes in bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase AST, gamma-glutamyl transpeptidase (GGTP), alkaline phosphatase,

  2. Change in degree of steatosis and fibrosis (fibroelastometry method). [ Time Frame: Baseline, Week 8 ]
    Degree of steatosis and fibrosis will evaluated via fibroelastometry method.

  3. Change in degree of steatosis and fibrosis (ultrasound method) [ Time Frame: Baseline, Week 8 ]
    Ultrasound will be used for assessment of steatosis and fibrosis.


Secondary Outcome Measures :
  1. Change in biochemical blood test results (cholesterol, glucose) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]
    Proportion of those with deviations from normal range will be reported and compared across periods and groups.

  2. Change in weight. [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]
    Frequency of patients with decreased weight will be detected and compared across groups/periods.

  3. Detection of general clinical symptoms of non-alcoholic steatohepatitis. [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]
    Symptoms such as of malaise, abdominal discomfort, vague right upper quadrant abdominal pain will be identified in patients during physical examination.



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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a verified diagnosis of non-alcoholic steatohepatitis;
  • Aged 16 to 60 years;
  • Absence of an allergic reaction to dairy products;
  • Willingness to consent to participate in the study.
  • Consent to adhere to treatment

Exclusion Criteria:

  • Taking antibiotics, cytostatics and steroids during the last 3 months;
  • Taking alcohol hepatotoxic doses (no more than 30 g alcohol per day for men and not more than 20 g for women);
  • History of oncological diseases;
  • Presence of diabetes mellitus, decompensated forms of diseases, intestinal dyspepsia, hypertension (blood pressure 140/90 mm Hg and more at the time of the initial visit to the doctor), tuberculosis;
  • A positive result of screening for antibodies to viral hepatitis B, C and D, as well as HIV
  • Presence of concomitant diseases of the kidneys, liver, cardiovascular, respiratory and other body systems, oncological, mental health and decompensated endocrine diseases, tuberculosis, and HIV infection;
  • Pregnancy and/or lactation;
  • Patient involvement in other clinical trials within the last 3 months;
  • 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): NCT03664596


Contacts
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Contact: Bakytzhan Bimbetov, MD, PhD +7701 383 6072 bimbetov2010@mail.ru

Locations
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Kazakhstan
Medical Centre Hospital of the President's Affairs Administration Recruiting
Astana, Kazakhstan, 010000
Contact: Bakytzhan Bimbetov, MD, PhD    +7701 383 6072    bimbetov2010@mail.ru   
Sub-Investigator: Abay Zhangabylov, MD, PhD         
Sub-Investigator: Marzhan Rakhimzhanova, MD, MPH         
Sponsors and Collaborators
Medical Centre Hospital of the President’s Affairs Administration, Republic of Kazakhstan
Eurasia Invest Ltd.
Ministry of Education and Science, Republic of Kazakhstan

Publications:

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Responsible Party: Medical Centre Hospital of the President’s Affairs Administration, Republic of Kazakhstan
ClinicalTrials.gov Identifier: NCT03664596     History of Changes
Other Study ID Numbers: UDP.NAS.01
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 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 Medical Centre Hospital of the President’s Affairs Administration, Republic of Kazakhstan:
Non-alcoholic Steatohepatitis
Mare milk
Immune markers

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents