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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03665519
Enrollment
40
Registered
2018-09-11
Start date
2018-01-03
Completion date
2020-12-01
Last updated
2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cirrhosis

Keywords

Primary Biliary Cirrhosis, Primary Biliary Cholangitis, Mare Milk

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTSublimated mare milk

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

DRUGUrsodeoxycholic Acid

Ursodeoxycholic acid treatment will be given for 3 months.

Sponsors

Eurasia Invest Ltd.
CollaboratorINDUSTRY
Ministry of Education and Science, Republic of Kazakhstan
CollaboratorOTHER_GOV
National Scientific Medical Center, Kazakhstan
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Biochemical changes in liver function.Baseline, Month 4Levels of alanine aminotransferase and aspartate aminotransferase will be measured from a biochemical blood test.
Change in intensity of asthenia in patients.Baseline, Month 4Intensity 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.
Evaluation of liver histology.Month 4Liver histology, histochemistry, immunohistochemistry will be evaluated based on biopsy samples.
Change from baseline in hepatic encephalopathy indicator.Baseline, Month 4Presence and stage of hepatic encephalopathy will be determined using the Reitan test (number connection test)

Secondary

MeasureTime frameDescription
Evaluation of changes in synthetic function of liver (albumin).Baseline, Month 4Synthetic function of liver will be evaluated from blood test results of albumin.
Evaluation of changes in low-density lipoprotein.Baseline, Month 4Synthetic function of liver will be evaluated from blood test results of low-density lipoprotein.
Evaluation of changes in total protein.Baseline, Month 4Synthetic function of liver will be evaluated from blood test results of total protein.
Change in inflammatory biomaker (erythrocyte sedimentation rate).Baseline, Month 4The erythrocyte sedimentation rate will be measured using the Panchenkov method
Detection of anemia.Baseline, Month 4Blood hemoglobin level will be used as a parameter for diagnosing anemia.
Hepatic hypertensionBaseline, Month 4Detection of hepatic hypertension will be carried out via platelet level assessment from the blood samples.
Evaluation of changes in platelet count.Baseline, Month 4Synthetic function of liver will be evaluated blood test results of platelet count.
Determination of cholestasis presence/stage.Baseline, Month 4Cholestasis will be assessed according to levels of gamma-glutamyltransferase, Alkaline phosphatase, direct bilirubin, total bilirubin from blood samples.
Evaluation of changes in synthetic function of liver (prothrombin time).Baseline, Month 4Synthetic function of liver will be evaluated from the blood test result of prothrombin time.
Evaluation of changes in synthetic function of liver (fibrinogen).Baseline, Month 4Synthetic function of liver will be evaluated from blood test results of fibrinogen, and platelet count.

Countries

Kazakhstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026