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

Non-alcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664596
• Other study ID #: UDP.NAS.01
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2021
• Source: Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Nonalcoholic steatohepatitis (NASH) is characterized by the liver damage in the form of fatty degeneration and hepatitis in people who do not abuse alcohol. The disease often develops in middle-aged women with excessive body weight, increased blood glucose and blood lipids, but can occur in all age groups and in both sexes. In most cases, the disease is asymptomatic. Laboratory data indicate an increase in the level of aminotransaminases. Ultrasound reveals hyperechoic tissue of the liver due to diffuse fatty infiltration. The degree of steatosis can also be estimated by a controlled attenuation parameter (CAP - Controlled Attenuation Parameter) in the fibroelastometry of liver tissue. It is also possible to verify the degree of fibrosis of liver tissue in its presence. Given that the mare's milk has therapeutic and dietary properties for various diseases of the internal organs, including liver diseases, the investigators decided to study its therapeutic effectiveness in NASH.

In this clinical study, the effectiveness of mare's milk in NASH will be studied in comparison with control groups taking monotherapy with ursodeoxycholic acid (UDCA) and combined therapy (mare's milk and UDCA). Patients will receive a sublimated form of mare's milk in the appropriate dosage within 2 months, and the results of clinical laboratory and instrumental studies will be compared among themselves using statistical methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

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

Drug:
• Ursodeoxycholic Acid
Ursodeoxycholic acid in the form of 250 mg capsule.

Locations

Country	Name	City	State
Kazakhstan	Medical Centre Hospital of the President's Affairs Administration	Astana

Sponsors (3)

Lead Sponsor	Collaborator
Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan	Eurasia Invest Ltd., Ministry of Education and Science, Republic of Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

References & Publications (12)

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. — View Citation

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. — View Citation

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.

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. -?.268-273.

Guri A, Paligot M, Crèvecoeur 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in degree of steatosis and fibrosis (fibroelastometry method).	Degree of steatosis and fibrosis will evaluated via fibroelastometry method.	Baseline, Week 8
Primary	Change in degree of steatosis and fibrosis (ultrasound method)	Ultrasound will be used for assessment of steatosis and fibrosis.	Baseline, Week 8
Secondary	Change in biochemical blood test results (cholesterol, glucose)	Proportion of those with deviations from normal range will be reported and compared across periods and groups.	Baseline, Week 2, Week 4, Week 6, Week 8
Secondary	Change in weight.	Frequency of patients with decreased weight will be detected and compared across groups/periods.	Baseline, Week 2, Week 4, Week 6, Week 8
Secondary	Detection of general clinical symptoms of non-alcoholic steatohepatitis.	Symptoms such as of malaise, abdominal discomfort, vague right upper quadrant abdominal pain will be identified in patients during physical examination.	Baseline, Week 2, Week 4, Week 6, Week 8