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

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.

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.

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

Levels of alanine aminotransferase and aspartate aminotransferase will be measured from a biochemical blood test.

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.

Presence and stage of hepatic encephalopathy will be determined using the Reitan test (number connection test)

Cholestasis will be assessed according to levels of gamma-glutamyltransferase, Alkaline phosphatase, direct bilirubin, total bilirubin from blood samples.

Synthetic function of liver will be evaluated from blood test results of fibrinogen, and platelet count.

Detection of hepatic hypertension will be carried out via platelet level assessment from the blood samples.

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

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