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Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis

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ClinicalTrials.gov Identifier: NCT03665519
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
Eurasia Invest Ltd.
Ministry of Education and Science, Republic of Kazakhstan
Information provided by (Responsible Party):
National Scientific Medical Center, Kazakhstan

Brief Summary:
This study evaluates the effect of sublimated mare milk supplement on patients with biliary cholangitis

Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Dietary Supplement: Sublimated mare milk Drug: Ursodeoxycholic Acid Not Applicable

Detailed Description:

Primary biliary cholangitis, formerly known as primary biliary cirrhosis, is a rare chronic disease that primarily affects women. Primary biliary cholangitis often progresses to the terminal stage of liver cirrhosis with its inherent complications. At this stage, the only way to save the patient's life is liver transplantation, and is accompanied by a number of painful symptoms (itching, mucous dryness, abdominal discomfort, fatigue), often restless legs syndrome, insomnia, depression and cognitive dysfunction.

The goal of the treatment is to prevent the terminal stage of cirrhosis of the liver and to alleviate the accompanying symptoms. Conventional drug therapy is aimed at slowing the progression of the disease and includes both approved for the use of these medications (ursodeoxycholic acid) and used outside the approved indications (derivatives of fibric acid, budesonide).

The role of this clinical trial is to increase the effectiveness of therapy for this disease. Against the background of the complexity of the treatment of primary biliary cholangitis, clinical medicine acquires a remedy in the form of a natural product - mare's milk, preventive, dietary, medicinal effects of which have been known for a long time. There are data from studies that have shown the efficacy and safety of using mare milk in patients with atopic dermatitis as well as with inflammatory bowel diseases. For the liver diseases, there are no reported studies.

In this trial, there will be two parallel groups: Interventional (supplement with standard treatment first for 3 months) and Standard treatment group. Differences in clinical, laboratory, liver encephalopathy and asthenia will be evaluated between groups.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial on the Effect of Sublimated Mare Milk Supplement in Patients With Biliary Cholangitis
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Dietary supplement and ursodeoxycholic acid therapy.
Participants will take a supplement (sublimated mare milk) of 1 sachet (20 mg) dissolved in 200 ml of warm water (36-37 °C) twice/day accompanied with standard therapy of ursodeoxycholic acid therapy (dosage of 15/kg/day) for 3 months.
Dietary Supplement: Sublimated mare milk
The dietary supplement mare milk product, which is obtained from fresh mare milk (few hours) through sublimation process.

Drug: Ursodeoxycholic Acid
Ursodeoxycholic acid treatment will be given for 3 months.

Ursodeoxycholic acid therapy only.
Patients would be given the standard treatment of ursodeoxycholic acid only for 3 months.
Drug: Ursodeoxycholic Acid
Ursodeoxycholic acid treatment will be given for 3 months.




Primary Outcome Measures :
  1. Biochemical changes in liver function. [ Time Frame: Baseline, Month 4 ]
    Levels of alanine aminotransferase and aspartate aminotransferase will be measured from a biochemical blood test.

  2. Change in intensity of asthenia in patients. [ Time Frame: Baseline, Month 4 ]
    Intensity of asthenia will be assessed with the State-Asthenic Scale by L. Malkova (adapted by Chertova) with scores less than 50 and more than 100 indicating no asthenia and pronounced asthenia respectively.

  3. Evaluation of liver histology. [ Time Frame: Month 4 ]
    Liver histology, histochemistry, immunohistochemistry will be evaluated based on biopsy samples.

  4. Change from baseline in hepatic encephalopathy indicator. [ Time Frame: Baseline, Month 4 ]
    Presence and stage of hepatic encephalopathy will be determined using the Reitan test (number connection test)


Secondary Outcome Measures :
  1. Change in inflammatory biomaker (erythrocyte sedimentation rate). [ Time Frame: Baseline, Month 4 ]
    The erythrocyte sedimentation rate will be measured using the Panchenkov method

  2. Determination of cholestasis presence/stage. [ Time Frame: Baseline, Month 4 ]
    Cholestasis will be assessed according to levels of gamma-glutamyltransferase, Alkaline phosphatase, direct bilirubin, total bilirubin from blood samples.

  3. Evaluation of changes in synthetic function of liver (prothrombin time). [ Time Frame: Baseline, Month 4 ]
    Synthetic function of liver will be evaluated from the blood test result of prothrombin time.

  4. Evaluation of changes in synthetic function of liver (fibrinogen). [ Time Frame: Baseline, Month 4 ]
    Synthetic function of liver will be evaluated from blood test results of fibrinogen, and platelet count.

  5. Evaluation of changes in synthetic function of liver (albumin). [ Time Frame: Baseline, Month 4 ]
    Synthetic function of liver will be evaluated from blood test results of albumin.

  6. Evaluation of changes in low-density lipoprotein. [ Time Frame: Baseline, Month 4 ]
    Synthetic function of liver will be evaluated from blood test results of low-density lipoprotein.

  7. Evaluation of changes in total protein. [ Time Frame: Baseline, Month 4 ]
    Synthetic function of liver will be evaluated from blood test results of total protein.

  8. Evaluation of changes in platelet count. [ Time Frame: Baseline, Month 4 ]
    Synthetic function of liver will be evaluated blood test results of platelet count.

  9. Detection of anemia. [ Time Frame: Baseline, Month 4 ]
    Blood hemoglobin level will be used as a parameter for diagnosing anemia.

  10. Hepatic hypertension [ Time Frame: Baseline, Month 4 ]
    Detection of hepatic hypertension will be carried out via platelet level assessment from the blood samples.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with morphologically verified diagnosis of primary biliary cholangitis
  • Aged 18 to 75 years
  • Willingness to consent to participate in the study
  • Consent to adhere to treatment

Exclusion Criteria:

  • Alcohol and/or drug dependence
  • Presence of liver cirrhosis class C based on Child Pugh classification
  • Allergic reaction to dairy products
  • Presence of mental diseases, severe concomitant pathology
  • Pregnancy and/or lactation
  • Lactose intolerance
  • 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): NCT03665519


Contacts
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Contact: Galiya Shaimardanova, PhD +77017299148 galiya_masugut@mail.ru
Contact: Gulmira Dossatayeva, MD, MBA +77015127500 g_dossatayeva@inbox.ru

Locations
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Kazakhstan
National Research Medical Center Recruiting
Astana, Kazakhstan, 010000
Contact: Galiya Shaimardanova, PhD    +77017299148    galiya_masugut@mail.ru   
Contact: Gulmira Dossatayeva, MD, MBA    +77015127500    g_dossatayeva@inbox.ru   
Principal Investigator: Abay Baigenzhin, MD, PhD         
Sub-Investigator: Gulmira Dossatayeva, MD, MBA         
Sub-Investigator: Maiya Zhumabayeva, MD         
Sub-Investigator: Galiya Shaimardanova, PhD         
Sponsors and Collaborators
National Scientific Medical Center, Kazakhstan
Eurasia Invest Ltd.
Ministry of Education and Science, Republic of Kazakhstan

Additional Information:
Publications:
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Responsible Party: National Scientific Medical Center, Kazakhstan
ClinicalTrials.gov Identifier: NCT03665519     History of Changes
Other Study ID Numbers: NNMC.MM.BC.01
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 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 National Scientific Medical Center, Kazakhstan:
Primary Biliary Cirrhosis
Primary Biliary Cholangitis
Mare Milk
Additional relevant MeSH terms:
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Cholangitis
Liver Cirrhosis, Biliary
Fibrosis
Pathologic Processes
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Cholestasis, Intrahepatic
Cholestasis
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents