Non-alcoholic SteatohepatitisNCT03664596

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

A study testing Sublimated mare's milk and Ursodeoxycholic Acid in people with Non-alcoholic Steatohepatitis, run by Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan at 1 site in Kazakhstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 16 to 60 years
Conditions the study is for: Non-alcoholic Steatohepatitis
What is being tested?: Sublimated mare's milk and Ursodeoxycholic Acid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteKazakhstan
Study dates: 1 Aug 2018to 1 Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 60 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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;

Show all 9Show fewer

Pregnancy and/or lactation;
Patient involvement in other clinical trials within the last 3 months;
Refusal to participate in the study.

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site

Medical Centre Hospital of the President's Affairs Administration
Astana, 010000

Other trials in Kazakhstan

About this study

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

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

Read the detailed 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.

Conditions: Non-alcoholic Steatohepatitis
Being tested: Sublimated mare's milk, Ursodeoxycholic Acid
Keywords: Non-alcoholic Steatohepatitis, Mare milk, Immune markers
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sublimated mare's milkDietary supplement
Supplement obtained through sublimation of mare milk, packed into one-dosage sachet (20g), and dissolved in a warm water (36 degrees of Celcius).
Ursodeoxycholic AcidDrug
Ursodeoxycholic acid in the form of 250 mg capsule.

Study groups in NCT03664596
Study group	Role	What they receive
Dietary supplement only	Experimental	Participants will take a sublimated mare milk of 1 sachet 3 times a day during 2 months. Receives: 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. Receives: 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. Receives: Drug: Ursodeoxycholic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

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,
Measured: 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.
Measured: Baseline, Week 8
Change in degree of steatosis and fibrosis (ultrasound method)
Ultrasound will be used for assessment of steatosis and fibrosis.
Measured: Baseline, Week 8

Secondary outcomes (3)

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.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8
Change in weight.
Frequency of patients with decreased weight will be detected and compared across groups/periods.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8
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.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20181 Dec 2020

First posted10 Sep 2018
Study start1 Aug 2018
Primary completion1 Sep 2020
Study completion1 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03664596
Sponsor's protocol ID: UDP.NAS.01
Status last verified: Feb 2021
First submitted: 6 Sep 2018
Last updated: 5 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 1123470
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.
PubMed 956472
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.
PubMed 26428623
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.
PubMed 27476815
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.
PubMed 24187469
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.
PubMed 23206305
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.
PubMed 10392421
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.
PubMed 22558569
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.
PubMed 26656278
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.
PubMed 30431378
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.
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-alcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation Of The Therapeutic And Dietary Properties Of The Sublimated Mare's Milk Supplement In Patients With Non-Alcoholic Steatohepatitis
ClinicalTrials.gov ID: NCT03664596
Acronym / sponsor ID: UDP.NAS.01
Conditions: Non-alcoholic Steatohepatitis
Keywords: Non-alcoholic Steatohepatitis, Mare milk, Immune markers
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Medical Centre Hospital of the President's Affairs Administration, Republic of KazakhstanOther government
Collaborators: Eurasia Invest Ltd., Ministry of Education and Science, Republic of Kazakhstan
Study start: 1 Aug 2018 (actual)
Primary completion: 1 Sep 2020 (actual)
Study completion: 1 Dec 2020 (actual)
First posted: 10 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dietary supplement only	Experimental	Dietary Supplement: Sublimated mare's milkParticipants will take a sublimated mare milk of 1 sachet 3 times a day during 2 months.
Dietary supplement and ursodeoxycholic acid therapy	Other	Dietary Supplement: Sublimated mare's milk, Drug: Ursodeoxycholic AcidPatients 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.
Ursodeoxycholic acid therapy only	Active comparator	Drug: Ursodeoxycholic AcidPatients with verified diagnosis of non-alcoholic steatohepatitis would be given treatment of ursodeoxycholic acid (2-3 times/day) for a two-month period.

Who may qualify

Ages: 16 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sublimated mare's milkSupplement obtained through sublimation of mare milk, packed into one-dosage sachet (20g), and dissolved in a warm water (36 degrees of Celcius).	Dietary supplement	Dietary supplement and ursodeoxycholic acid therapy, Dietary supplement only
Ursodeoxycholic AcidUrsodeoxycholic acid in the form of 250 mg capsule.	Drug	Dietary supplement and ursodeoxycholic acid therapy, Ursodeoxycholic acid therapy only

Primary outcome

Change in liver function indicators
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Blood samples will be taken to determine changes in bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase AST, gamma-glutamyl transpeptidase (GGTP), alkaline phosphatase,
Change in degree of steatosis and fibrosis (fibroelastometry method).
Time frame: Baseline, Week 8
Degree of steatosis and fibrosis will evaluated via fibroelastometry method.
Change in degree of steatosis and fibrosis (ultrasound method)
Time frame: Baseline, Week 8
Ultrasound will be used for assessment of steatosis and fibrosis.

3 secondary outcomes

Change in biochemical blood test results (cholesterol, glucose)
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Change in weight.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Detection of general clinical symptoms of non-alcoholic steatohepatitis.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
Background: PubMed 1123470Sidhu 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.
Background: PubMed 956472Sidhu 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.
Background: PubMed 26428623Rong 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.
Background: PubMed 27476815Aryantini 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.
Background: PubMed 24187469Ma 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.
Background: PubMed 23206305Zhang 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.
Background: PubMed 10392421Valiev 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.
Background: PubMed 22558569Abdel-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.
Background: PubMed 26656278Guri 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.
Results publication: PubMed 30431378Oshakbayev 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.
Results publicationBimbetov 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.
Results publicationBimbetov 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in liver function indicators (time frame: Baseline, Week 2, Week 4, Week 6, Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03664596, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.