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

NCT03665519 | Completed

• 1 other identifier: NNMC.MM.BC.01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Biliary Cirrhosis

Keywords

Primary Biliary Cirrhosis; Primary Biliary Cholangitis; Mare Milk

Outcome Measures

Primary Outcomes (4)

• Biochemical changes in liver function.

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

  Baseline, Month 4

• Change in intensity of asthenia in patients.

  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.

  Baseline, Month 4

• Evaluation of liver histology.

  Liver histology, histochemistry, immunohistochemistry will be evaluated based on biopsy samples.

  Month 4

• Change from baseline in hepatic encephalopathy indicator.

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

  Baseline, Month 4

Secondary Outcomes (10)

• Change in inflammatory biomaker (erythrocyte sedimentation rate).

  Baseline, Month 4

• Determination of cholestasis presence/stage.

  Baseline, Month 4

• Evaluation of changes in synthetic function of liver (prothrombin time).

  Baseline, Month 4

• Evaluation of changes in synthetic function of liver (fibrinogen).

  Baseline, Month 4

• Evaluation of changes in synthetic function of liver (albumin).

  Baseline, Month 4

Study Arms (2)

Dietary supplement and ursodeoxycholic acid therapy.

EXPERIMENTAL

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.

Dietary Supplement: Sublimated mare milk; Drug: Ursodeoxycholic Acid

Ursodeoxycholic acid therapy only.

OTHER

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

Drug: Ursodeoxycholic Acid

Interventions

Sublimated mare milk DIETARY_SUPPLEMENT

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

Dietary supplement and ursodeoxycholic acid therapy.

Ursodeoxycholic Acid DRUG

Ursodeoxycholic acid treatment will be given for 3 months.

Dietary supplement and ursodeoxycholic acid therapy.; Ursodeoxycholic acid therapy only.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Scientific Medical Center, Kazakhstan: lead
• Eurasia Invest Ltd.: collaborator
• Ministry of Education and Science, Republic of Kazakhstan: collaborator

Study Sites (1)

National Research Medical Center

Astana, 010000, Kazakhstan

Location

Related Publications (4)

• 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.

  PMID: 19462320 BACKGROUND

• 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.

  PMID: 26656278 BACKGROUND

• 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.

  PMID: 10392421 BACKGROUND

• 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.

  PMID: 23035710 BACKGROUND

Related Links

• Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 11, 2018
• Study Start: January 3, 2018
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)