Therapeutic And Dietary Effects Of The Sublimated Mare's Milk Supplement In Patients With Non-Alcoholic Steatohepatitis

NCT03664596 | Completed

• 1 other identifier: UDP.NAS.01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the dietary and therapeutic effect of supplement consisting of sublimated mare milk among patients with non-alcoholic steatohepatitis.

Conditions

Non-alcoholic Steatohepatitis

Keywords

Non-alcoholic Steatohepatitis; Mare milk; Immune markers

Outcome Measures

Primary Outcomes (3)

• Change in liver function indicators

  Blood samples will be taken to determine changes in bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase AST, gamma-glutamyl transpeptidase (GGTP), alkaline phosphatase,

  Baseline, Week 2, Week 4, Week 6, Week 8

• Change in degree of steatosis and fibrosis (fibroelastometry method).

  Degree of steatosis and fibrosis will evaluated via fibroelastometry method.

  Baseline, Week 8

• Change in degree of steatosis and fibrosis (ultrasound method)

  Ultrasound will be used for assessment of steatosis and fibrosis.

  Baseline, Week 8

Secondary Outcomes (3)

• Change in biochemical blood test results (cholesterol, glucose)

  Baseline, Week 2, Week 4, Week 6, Week 8

• Change in weight.

  Baseline, Week 2, Week 4, Week 6, Week 8

• Detection of general clinical symptoms of non-alcoholic steatohepatitis.

  Baseline, Week 2, Week 4, Week 6, Week 8

Study Arms (3)

Dietary supplement only

EXPERIMENTAL

Participants will take a sublimated mare milk of 1 sachet 3 times a day during 2 months.

Dietary Supplement: Sublimated mare's milk

Dietary supplement and ursodeoxycholic acid therapy

OTHER

Patients with non-alcoholic steatohepatitis will take ursodeoxycholic acid (2-3 times/day) combined with the mare's milk supplement (1 sachet, 3 times/day) for two months.

Dietary Supplement: Sublimated mare's milk; Drug: Ursodeoxycholic Acid

Ursodeoxycholic acid therapy only

ACTIVE COMPARATOR

Patients with verified diagnosis of non-alcoholic steatohepatitis would be given treatment of ursodeoxycholic acid (2-3 times/day) for a two-month period.

Drug: Ursodeoxycholic Acid

Interventions

Sublimated mare's milk DIETARY_SUPPLEMENT

Supplement obtained through sublimation of mare milk, packed into one-dosage sachet (20g), and dissolved in a warm water (36 degrees of Celcius).

Dietary supplement and ursodeoxycholic acid therapy; Dietary supplement only

Ursodeoxycholic Acid DRUG

Ursodeoxycholic acid in the form of 250 mg capsule.

Dietary supplement and ursodeoxycholic acid therapy; Ursodeoxycholic acid therapy only

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with a verified diagnosis of non-alcoholic steatohepatitis;
• Aged 16 to 60 years;
• Absence of an allergic reaction to dairy products;
• Willingness to consent to participate in the study.
• Consent to adhere to treatment

You may not qualify if:

• Taking antibiotics, cytostatics and steroids during the last 3 months;
• Taking alcohol hepatotoxic doses (no more than 30 g alcohol per day for men and not more than 20 g for women);
• History of oncological diseases;
• Presence of diabetes mellitus, decompensated forms of diseases, intestinal dyspepsia, hypertension (blood pressure 140/90 mm Hg and more at the time of the initial visit to the doctor), tuberculosis;
• A positive result of screening for antibodies to viral hepatitis B, C and D, as well as HIV
• Presence of concomitant diseases of the kidneys, liver, cardiovascular, respiratory and other body systems, oncological, mental health and decompensated endocrine diseases, tuberculosis, and HIV infection;
• Pregnancy and/or lactation;
• Patient involvement in other clinical trials within the last 3 months;
• Refusal to participate in the study.

Sponsors & Collaborators

• Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan: lead
• Eurasia Invest Ltd.: collaborator
• Ministry of Education and Science, Republic of Kazakhstan: collaborator

Study Sites (1)

Medical Centre Hospital of the President's Affairs Administration

Astana, 010000, Kazakhstan

Location

Related Publications (12)

• Sidhu GS, Brown MA, Johnson AR. Autoxidation in milk rich in linoleic acid. I. An objective method of measuring autoxidation and evaluating antioxidants. J Dairy Res. 1975 Feb;42(1):185-95. doi: 10.1017/s0022029900015211.

  PMID: 1123470 BACKGROUND

• Sidhu GS, Brown MA, Johnson AR. Autoxidation in milk rich in linoleic acid. II. Modification of the initiation system and control of oxidation. J Dairy Res. 1976 Jun;43(2):239-50. doi: 10.1017/s002202990001579x.

  PMID: 956472 BACKGROUND

• Rong J, Zheng H, Liu M, Hu X, Wang T, Zhang X, Jin F, Wang L. Probiotic and anti-inflammatory attributes of an isolate Lactobacillus helveticus NS8 from Mongolian fermented koumiss. BMC Microbiol. 2015 Oct 2;15:196. doi: 10.1186/s12866-015-0525-2.

  PMID: 26428623 BACKGROUND

• Aryantini NP, Yamasaki E, Kurazono H, Sujaya IN, Urashima T, Fukuda K. In vitro safety assessments and antimicrobial activities of Lactobacillus rhamnosus strains isolated from a fermented mare's milk. Anim Sci J. 2017 Mar;88(3):517-525. doi: 10.1111/asj.12668. Epub 2016 Aug 1.

  PMID: 27476815 BACKGROUND

• Ma YY, Li L, Yu CH, Shen Z, Chen LH, Li YM. Effects of probiotics on nonalcoholic fatty liver disease: a meta-analysis. World J Gastroenterol. 2013 Oct 28;19(40):6911-8. doi: 10.3748/wjg.v19.i40.6911.

  PMID: 24187469 BACKGROUND

• Zhang B, Lu XL, Song YH, Shi HT, Li J, Geng Y. [Changes in the intestinal microenvironment during development of alcoholic fatty liver disease and related effects of probiotic therapy]. Zhonghua Gan Zang Bing Za Zhi. 2012 Nov;20(11):848-52. doi: 10.3760/cma.j.issn.1007-3418.2012.11.010. Chinese.

  PMID: 23206305 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

• Abdel-Salam AM, Al-Dekheil A, Babkr A, Farahna M, Mousa HM. High fiber probiotic fermented mare's milk reduces the toxic effects of mercury in rats. N Am J Med Sci. 2010 Dec;2(12):569-75. doi: 10.4297/najms.2010.2569.

  PMID: 22558569 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

• Oshakbayev K, Bimbetov B, Manekenova K, Bedelbayeva G, Mustafin K, Dukenbayeva B. Severe nonalcoholic steatohepatitis and type 2 diabetes: liver histology after weight loss therapy in a randomized clinical trial. Curr Med Res Opin. 2019 Jan;35(1):157-165. doi: 10.1080/03007995.2018.1547696. Epub 2018 Nov 28.

  PMID: 30431378 RESULT

• Bimbetov B., Zhangabylov A., Aitbaeva S., Rakhimzhanova M, Bakytzhanuly A. The result of taking mare's milk for nonalcoholic steatohepatitis // Journal of Global Pharma Technology. Volume 11 Issue 08 (2019) August 2019. -Р.268-273.

  RESULT

• Bimbetov B., Zhangabylov A., Aitbaeva S., Bakytzhanuly A., Utepbergenova G. Use of the mare's milk of the treatment of non-alcoholic steatohepatitis // Systematic Reviews in Pharmacy. -2020.

  RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

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 10, 2018
• Study Start: August 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)