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NCT Number: NCT03665519

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

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

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Key information

Conditions

Primary Biliary Cirrhosis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Research Medical Center

Astana, 010000, Kazakhstan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sublimated mare milk

Dietary Supplement

The dietary supplement mare milk product, which is obtained from fresh mare milk (few hours) through sublimation process.

Ursodeoxycholic acid

Drug

Ursodeoxycholic acid treatment will be given for 3 months.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Scientific Medical Center, Kazakhstan

Other Gov

Collaborators

  • Eurasia Invest Ltd.
  • Ministry of Education and Science, Republic of Kazakhstan

Registry information

Official study title

Clinical Trial on the Effect of Sublimated Mare Milk Supplement in Patients With Biliary Cholangitis

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2018
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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