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

January 23, 2021 updated by: National Scientific Medical Center, Kazakhstan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • National Research Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 4
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.
Baseline, Month 4
Evaluation of liver histology.
Time Frame: Month 4
Liver histology, histochemistry, immunohistochemistry will be evaluated based on biopsy samples.
Month 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)
Baseline, Month 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inflammatory biomaker (erythrocyte sedimentation rate).
Time Frame: Baseline, Month 4
The erythrocyte sedimentation rate will be measured using the Panchenkov method
Baseline, Month 4
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.
Baseline, Month 4
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.
Baseline, Month 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.
Baseline, Month 4
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.
Baseline, Month 4
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.
Baseline, Month 4
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.
Baseline, Month 4
Evaluation of changes in platelet count.
Time Frame: Baseline, Month 4
Synthetic function of liver will be evaluated blood test results of platelet count.
Baseline, Month 4
Detection of anemia.
Time Frame: Baseline, Month 4
Blood hemoglobin level will be used as a parameter for diagnosing anemia.
Baseline, Month 4
Hepatic hypertension
Time Frame: Baseline, Month 4
Detection of hepatic hypertension will be carried out via platelet level assessment from the blood samples.
Baseline, Month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Scientific Medical Center, Kazakhstan

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2018

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 23, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NNMC.MM.BC.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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