Primary Biliary CirrhosisNCT03665519

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

A study testing Sublimated mare milk and Ursodeoxycholic Acid in people with Primary Biliary Cirrhosis, run by National Scientific Medical Center, 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 effect of sublimated mare milk supplement on patients with biliary cholangitis Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Primary Biliary Cirrhosis
What is being tested?: Sublimated mare milk and Ursodeoxycholic Acid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteKazakhstan
Study dates: 3 Jan 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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site

National Research Medical Center
Astana, 010000

Other trials in Kazakhstan

About this study

Official title: Clinical Trial on the Effect of Sublimated Mare Milk Supplement in Patients With Biliary Cholangitis

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

Read the 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.

Conditions: Primary Biliary Cirrhosis
Being tested: Sublimated mare milk, Ursodeoxycholic Acid
Keywords: Primary Biliary Cirrhosis, Primary Biliary Cholangitis, Mare Milk
Medical subject headings: Liver Cirrhosis, Biliary

What participants receive

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

Sublimated mare milkDietary supplement
The dietary supplement mare milk product, which is obtained from fresh mare milk (few hours) through sublimation process.
Ursodeoxycholic AcidDrug
Ursodeoxycholic acid treatment will be given for 3 months.

Study groups in NCT03665519
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Ursodeoxycholic Acid

What is being measured

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

Biochemical changes in liver function.
Levels of alanine aminotransferase and aspartate aminotransferase will be measured from a biochemical blood test.
Measured: 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.
Measured: Baseline, Month 4
Evaluation of liver histology.
Liver histology, histochemistry, immunohistochemistry will be evaluated based on biopsy samples.
Measured: 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)
Measured: Baseline, Month 4

Secondary outcomes (10)

Change in inflammatory biomaker (erythrocyte sedimentation rate).
The erythrocyte sedimentation rate will be measured using the Panchenkov method
Measured: Baseline, Month 4
Determination of cholestasis presence/stage.
Cholestasis will be assessed according to levels of gamma-glutamyltransferase, Alkaline phosphatase, direct bilirubin, total bilirubin from blood samples.
Measured: Baseline, Month 4
Evaluation of changes in synthetic function of liver (prothrombin time).
Synthetic function of liver will be evaluated from the blood test result of prothrombin time.
Measured: Baseline, Month 4
Evaluation of changes in synthetic function of liver (fibrinogen).
Synthetic function of liver will be evaluated from blood test results of fibrinogen, and platelet count.
Measured: Baseline, Month 4
Evaluation of changes in synthetic function of liver (albumin).
Synthetic function of liver will be evaluated from blood test results of albumin.
Measured: Baseline, Month 4
Evaluation of changes in low-density lipoprotein.
Synthetic function of liver will be evaluated from blood test results of low-density lipoprotein.
Measured: Baseline, Month 4
Evaluation of changes in total protein.
Synthetic function of liver will be evaluated from blood test results of total protein.
Measured: Baseline, Month 4
Evaluation of changes in platelet count.
Synthetic function of liver will be evaluated blood test results of platelet count.
Measured: Baseline, Month 4
Detection of anemia.
Blood hemoglobin level will be used as a parameter for diagnosing anemia.
Measured: Baseline, Month 4
Hepatic hypertension
Detection of hepatic hypertension will be carried out via platelet level assessment from the blood samples.
Measured: Baseline, Month 4

Timeline

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

3 Jan 20181 Dec 2020

First posted11 Sep 2018
Study start3 Jan 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 (4)Papers the sponsor has linked to this study.
Other trials for Primary Biliary CirrhosisStudies 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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03665519
Sponsor's protocol ID: NNMC.MM.BC.01
Status last verified: Jan 2021
First submitted: 6 Sep 2018
Last updated: 26 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 19462320
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
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
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.
PubMed 23035710

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

Active, not recruitingPhase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
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RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
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RecruitingPhase 3
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
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RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis

All Primary Biliary Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial on the Effect of Sublimated Mare Milk Supplement in Patients With Biliary Cholangitis
ClinicalTrials.gov ID: NCT03665519
Acronym / sponsor ID: NNMC.MM.BC.01
Conditions: Primary Biliary Cirrhosis
Keywords: Primary Biliary Cirrhosis, Primary Biliary Cholangitis, Mare Milk
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: National Scientific Medical Center, KazakhstanOther government
Collaborators: Eurasia Invest Ltd., Ministry of Education and Science, Republic of Kazakhstan
Study start: 3 Jan 2018 (actual)
Primary completion: 1 Sep 2020 (actual)
Study completion: 1 Dec 2020 (actual)
First posted: 11 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 effect of sublimated mare milk supplement on patients with biliary cholangitis

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dietary supplement and ursodeoxycholic acid therapy.	Experimental	Dietary Supplement: Sublimated mare milk, Drug: Ursodeoxycholic AcidParticipants 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.
Ursodeoxycholic acid therapy only.	Other	Drug: Ursodeoxycholic AcidPatients would be given the standard treatment of ursodeoxycholic acid only for 3 months.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

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 milkThe dietary supplement mare milk product, which is obtained from fresh mare milk (few hours) through sublimation process.	Dietary supplement	Dietary supplement and ursodeoxycholic acid therapy.
Ursodeoxycholic AcidUrsodeoxycholic acid treatment will be given for 3 months.	Drug	Dietary supplement and ursodeoxycholic acid therapy., Ursodeoxycholic acid therapy only.

Primary outcome

Biochemical changes in liver function.
Time frame: Baseline, Month 4
Levels of alanine aminotransferase and aspartate aminotransferase will be measured from a biochemical blood test.
Change in intensity of asthenia in patients.
Time frame: Baseline, Month 4
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.
Evaluation of liver histology.
Time frame: Month 4
Liver histology, histochemistry, immunohistochemistry will be evaluated based on biopsy samples.
Change from baseline in hepatic encephalopathy indicator.
Time frame: Baseline, Month 4
Presence and stage of hepatic encephalopathy will be determined using the Reitan test (number connection test)

10 secondary outcomes

Change in inflammatory biomaker (erythrocyte sedimentation rate).
Time frame: Baseline, Month 4
Determination of cholestasis presence/stage.
Time frame: Baseline, Month 4
Evaluation of changes in synthetic function of liver (prothrombin time).
Time frame: Baseline, Month 4
Evaluation of changes in synthetic function of liver (fibrinogen).
Time frame: Baseline, Month 4
Evaluation of changes in synthetic function of liver (albumin).
Time frame: Baseline, Month 4
Evaluation of changes in low-density lipoprotein.
Time frame: Baseline, Month 4
Evaluation of changes in total protein.
Time frame: Baseline, Month 4
Evaluation of changes in platelet count.
Time frame: Baseline, Month 4
Detection of anemia.
Time frame: Baseline, Month 4
Hepatic hypertension
Time frame: Baseline, Month 4

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 26 Jan 2021.
Background: PubMed 19462320Foekel 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.
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.
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 23035710Wulijideligen, 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.
Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel DiseasesLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Primary Biliary Cirrhosis

Active, not recruitingPhase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
RecruitingPhase 3
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis

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?

A study testing Sublimated mare milk and Ursodeoxycholic Acid in people with Primary Biliary Cirrhosis, run by National Scientific Medical Center, Kazakhstan at 1 site in Kazakhstan.

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 4 inclusion and 7 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 26 Jan 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?

Biochemical changes in liver function. (time frame: Baseline, Month 4). The study lists 4 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 NCT03665519, which also lists 4 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 26 Jan 2021.