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

National Scientific Medical Center, Kazakhstan

Status: Completed

Conditions: Primary Biliary Cirrhosis

Treatments: Drug: Ursodeoxycholic Acid; Dietary Supplement: Sublimated mare milk

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03665519

NNMC.MM.BC.01

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Dietary supplement and ursodeoxycholic acid therapy.

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Sublimated mare milk

Drug: Ursodeoxycholic Acid

Ursodeoxycholic acid therapy only.

Other group

Description:

Patients would be given the standard treatment of ursodeoxycholic acid only for 3 months.

Treatment:

Drug: Ursodeoxycholic Acid