Clinical trial NCT03665519: Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis
Official title: Clinical Trial on the Effect of Sublimated Mare Milk Supplement in Patients With Biliary Cholangitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Biliary Cirrhosis
Keywords: Primary Biliary Cirrhosis
Primary Biliary Cholangitis
Mare Milk
Lead sponsor: National Scientific Medical Center, Kazakhstan
Sponsor class: OTHER_GOV
Collaborators: name: Eurasia Invest Ltd.
name: Ministry of Education and Science, Republic of Kazakhstan
First posted: 2018-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biochemical changes in liver function.
timeFrame: Baseline, Month 4
measure: Change in intensity of asthenia in patients.
timeFrame: Baseline, Month 4
measure: Evaluation of liver histology.
timeFrame: Month 4
measure: Change from baseline in hepatic encephalopathy indicator.
timeFrame: Baseline, Month 4
Secondary outcomes:
measure: Change in inflammatory biomaker (erythrocyte sedimentation rate).
timeFrame: Baseline, Month 4
measure: Determination of cholestasis presence/stage.
timeFrame: Baseline, Month 4
measure: Evaluation of changes in synthetic function of liver (prothrombin time).
timeFrame: Baseline, Month 4
measure: Evaluation of changes in synthetic function of liver (fibrinogen).
timeFrame: Baseline, Month 4
measure: Evaluation of changes in synthetic function of liver (albumin).
timeFrame: Baseline, Month 4
measure: Evaluation of changes in low-density lipoprotein.
timeFrame: Baseline, Month 4
measure: Evaluation of changes in total protein.
timeFrame: Baseline, Month 4
measure: Evaluation of changes in platelet count.
timeFrame: Baseline, Month 4
measure: Detection of anemia.
timeFrame: Baseline, Month 4
measure: Hepatic hypertension
timeFrame: Baseline, Month 4
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: National Research Medical Center
Study officials:
References:
citation: Foekel C, Schubert R, Kaatz M, Schmidt I, Bauer A, Hipler UC, Vogelsang H, Rabe K, Jahreis G. Dietetic effects of oral intervention with mare's milk on the Severity Scoring of Atopic Dermatitis, on faecal microbiota and on immunological parameters in patients with atopic dermatitis. Int J Food Sci Nutr. 2009;60 Suppl 7:41-52. doi: 10.1080/09637480802249082. Epub 2009 May 21.
citation: Guri A, Paligot M, Crevecoeur S, Piedboeuf B, Claes J, Daube G, Corredig M, Griffiths MW, Delcenserie V. In vitro screening of mare's milk antimicrobial effect and antiproliverative activity. FEMS Microbiol Lett. 2016 Jan;363(2):fnv234. doi: 10.1093/femsle/fnv234. Epub 2015 Dec 9.
citation: Valiev AG, Valieva TA, Valeeva GR, Speranskii VV, Levachev MM. [The effect of the essential fatty acids in mare's milk on the function of the immune system and of nonspecific resistance in rats]. Vopr Pitan. 1999;68(3):3-6. Russian.
citation: Wulijideligen, Asahina T, Hara K, Arakawa K, Nakano H, Miyamoto T. Production of bacteriocin by Leuconostoc mesenteroides 406 isolated from Mongolian fermented mare's milk, airag. Anim Sci J. 2012 Oct;83(10):704-11. doi: 10.1111/j.1740-0929.2012.01010.x. Epub 2012 Mar 13.