DYNAMICS OF MARKERS OF INTRAHEPATIC CHOLESTASIS IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS WHEN APPLYING AN INTEGRATED PROTEIN-AMINO ACID AND VITAMIN PRODUCT (MARE’S MILK)

Abstract

Introduction: Primary biliary cholangitis (PBC), formerly primary biliary cirrhosis, is a rare progressive cholestatic liver
disease, whose hallmark features include a persistently elevated alkaline phosphatase level, presence of anti‐mitochondrial
antibodies (AMA) and characteristic histology. For 30 yearsursodeoxycholic acid (UDCA), a bile acid, has been the only
available therapeutic agent. PBC is associated with the development of end‐stage liver disease, increased morbidity and
mortality. UDCA has been shown to improve serum biochemistries, histology and delay the need for liver transplantation.
The clinical issue is that approximately 25%‐40% of patients do not respond to this standard therapy. In recent years, many
trials have investigated alternative and adjunctive treatments.In way of the search for a safe and effective treatment for PBC
mares milk acquires high potential in terms of affecting one of the links in the pathogenesis of PBC by modeling the
composition of the intestinal microbiome. The intestinal microbiome plays an important role in the pathogenesis of PBC by
regulating bile acid metabolism and immune responses.
The aim of the study – to evaluate the effect of a complex protein-amino acid and vitamin product (mares milk) on the
indicators of markers of intrahepatic cholestasis in patients with PBC (primary endpoint).
Material and methods of the study. From September 2018 to the present time, an interventional non-randomised
clinical trial (identifier NCT03665519) has been conducted in National Scientific Medical Center and currently, 23 patients
have completed the study. Inclusion сriteria: Patients with verified diagnosis of PBC, aged 18 to 75 years. Exclusion criteria:
alcohol and/or drug dependence, presence of liver cirrhosis class C based on Child Pugh classification, allergic reaction to
dairy products, pesence of mental diseases, severe concomitant pathology, regnancy and/or lactation, lactose intolerance.
Participants from experimental (main) group were administered a supplement (sublimated mare milk 40 g/day) for 3 months
accompanied with standard UDCA therapy (dosage of 15/kg/day). PBC patients from control group were administered only
UDCA therapy (dosage of 15/kg/day). Markers of intrahepatic cholestasis were evaluated: gamma-glutamyltranspeptidase
(GGT) and alkaline phosphatase (ALP) at the beginning of the study and after 3 months in patients of both groups.
Comparison of the dynamics between the groups was carried out in the context of visits using the one-way analysis of
variance based on the Fisher criterion and the non-parametric Kruskal-Wallis test.
The level of statistical significance in the comparative analysis was adopted at 0.95 (α = 0.95). It means the expected
level of reliability, statistical significance, at which the null hypothesis of the absence of statistical differences in the
comparative analysis is rejected, should be less than 0.05 (p <0.05).
The results of the study. In patients of the main group, the level of ALP was significantly reduced to 6,72 ± 0,632
compared with the observation in the control group (9,30 ± 1,553). Comparing the dynamic level of GGTP in patients of the
main group, this indicator was significantly reduced to 3.88 ± 0.611 compared with the control group (5.53 ± 0.770). The
study showed a significant decrease in the main markers of intrahepatic cholestasis in patients with complex protein-protein
and vitamin product (mare's milk).
The conclusion: The study showed a significant decrease in the main markers of intrahepatic cholestasis in patients
after taking complex protein-amino acid and vitamin product (mares milk). Thus, the use of mares milk is an effective addition
to the standard therapy of PBC.