Acute BronchitisNCT03657836
The Sublimated Mare Milk Supplement's Effect on Gut Mucosal Lining After Antibiotics
A study testing Sublimated mare milk supplement and Standard antibiotic therapy in people with Acute Bronchitis, run by Nazarbayev University Medical Center at 1 site in Kazakhstan.
Trial summary
This clinical trial studies the effect of sublimated mare milk supplement on gut microbiome of patients with acute bronchitis. Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- Sublimated mare milk supplement and Standard antibiotic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 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 4 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients of both sexes aged 4-5 years
- The voluntary informed consent of the parent to participate in the study
- Established diagnosis of acute upper respiratory tract disease with prescription of antibacterial therapy
- The duration of symptoms of acute upper respiratory tract disease no more than 72 hours
- Lack of prescription of antibacterial drugs in the last 3 months
Who cannot join
- Severe forms of acute infections
- The presence in the history of taking probiotics and antibiotics for three months before admission to hospital
- Presence in the anamnesis of chronic diseases of the digestive tract, and also of any surgeries on the digestive tract
- The presence of severe concomitant diseases of the kidneys, liver, cardiovascular, respiratory and other body systems, cancer, mental and decompensated endocrine diseases, tuberculosis, HIV infection
- Patient involvement in other clinical trials within the last 3 months
- Lack of willingness of the patient to cooperate with the doctor-researcher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Effectiveness of the Sublimated Mare Milk Supplement in Protection of Gut Mucosal Lining During Antibiotic Treatment
This clinical trial studies the effect of sublimated mare milk supplement on gut microbiome of patients with acute bronchitis.
Read the detailed description
Food has a significant effect on the health of the body, the relationship between diet and health actualizes the importance of expanding the research of functional products. In mare's milk contains about 40 biological components necessary for the human body: amino acids, fats, enzymes (lysozyme, amylase), microelements (calcium, sodium, potassium, phosphorus, iron, magnesium, copper, iodine, sulfur, cobalt, zinc, bromine) and vitamins (A, C, B1, B2, B6, B12, E, H, PP, beta-carotene, folic acid) in optimally balanced proportions.
A high percentage of nutrients, including vitamins, amino acids, contribute to immunomodulation, increasing the adaptogenic properties of the body. Valiev A demonstrated the effect of the essential fatty acids of mare's milk on immunocompetent cells and non-specific resistance after 6 weeks from the beginning of inclusion in the ration of mare's milk.
Secretory IgA is the main immunoglobulin of mare's milk. The homology of human secretory IgA and mare's was previously demonstrated by cross-reactions using human anti-IgA antiserum.
The mare's milk has a powerful detoxification effect, the mare's microflora neutralizes the effect of mutagens, possesses, replenishes with the necessary complex of nutrients and removes toxins from the body. The milk has a certain degree of antimicrobial effect in relation to opportunistic and pathogenic fungi, bacteria and viruses due to its own microflora.
The mare's milk is rich in active substances, natural enzymes that help regulate intestinal flora, limiting the growth of unwanted bacteria and increasing the growth of bifidobacteria and lactic acid bacteria.
In addition, the composition of mare's milk provided immunoglobulins A, M and G, which act as a marker of those microorganisms that can be pathogenic, which facilitates the protection task.
The high antimicrobial activity of mare's milk is associated with the lysozyme contained in it, immunoglobulins, lactoperoxidase and lactoferrin. Getting into the digestive tract lysozyme has a powerful normalizing effect on the composition of the microbial flora of the mouth and intestines. Lysozyme of breast milk is 100 times more active than lysozyme of cow's milk. It not only inhibits the growth of pathogenic flora, but also promotes the growth of bifidoflora in the intestines of infants.
In the framework of the project, methods for the restoration of the mucos layer of the intestine after antibiotic therapy will be developed. In order to develop the algorithm, preliminary studies will be made of changes in the structure of the intestinal microbiota after antibiotic therapy. Recruiting of patients with infectious / non-infectious pathology is supposed, clinical and laboratory examination, biomaterial sampling during antibiotic therapy, 1-5 days and 1-60 days after completion will be performed. Along with the study of microflora, local immunity studies will be carried out. To study the fundamental foundations, experimental studies will be carried out on laboratory animals. On the basis of the knowledge obtained, an algorithm for the restoration of the mucinous layer of the intestine after antibiotic therapy will be published in the form of methodological recommendations.
- Conditions
- Acute Bronchitis
- Being tested
- Sublimated mare milk supplement, Standard antibiotic therapy
- Keywords
- Acute Bronchitis, Mare milk, Gut mucosa, Antibiotics
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublimated mare milk supplementDietary supplement
The dietary supplement consisting of sublimated mare milk packed in single-dose sachet.
Standard antibiotic therapyDrug
Patients will be given standard therapy antibiotics cefuroxime and ceftriaxone for up to 7 days period.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement and antibiotics | Experimental | Participants will take a supplement of 1 sachet (20 mg) dissolved in 200 ml of warm water (36-37 °C) once a day for 60 days accompanied with the standard antibiotic therapy (cefuroxime and ceftriaxone) up to 7 days. Receives: Dietary Supplement: Sublimated mare milk supplement; Drug: Standard antibiotic therapy |
| Antibiotics only | Other | Participants will take the prescribed antibiotic therapy (cefuroxime and ceftriaxone) up to 7 days. Receives: Drug: Standard antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intestinal microbial composition
Rectal swabs will be taken for further analysis of DNA sequence with MiSeq Reporter PCR Amplicon.
Measured: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 10, Day 15, Day 20, Day 25, Day 30, Day 35, Day 40, Day 45, Day 50, Day 55, Day 60
Changes in intestinal immune status biomarkers.
Levels of immune markers (cytokines, secretory Immunoglobulin A, interleukins) will be assessed from stool samples.
Measured: Baseline, Day 60
Secondary outcomes (4)
Changes in weight of the patient
Weight will be assessed according to percentile tables
Measured: Baseline, Day 60
Defecation frequency
Defecation frequency based on patient's/parent's/guardian's reports over period of 60 days
Measured: Baseline, up to 60 days
Changes in consistency of stool
Consistency of stool will be evaluated according to Bristol scale with severe hard lumps and liquid stool being a severe constipation (Type 1) and severe diarrhea (Type 7) respectively.
Measured: Baseline, Day 60
Changes in color of stool,
Stool color changes will be assessed based on baseline and final visit (Day 60).
Measured: Baseline, Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Aug 2018
- Primary completion20 Jan 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute BronchitisStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazarbayev University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eurasia Invest Ltd., Ministry of Education and Science, Republic of Kazakhstan
- Responsible party
- Principal investigator, Almagul Kushugulova, Nazarbayev University Medical Center
- Investigators
- Almagul Kushugulova, MD, PhD, Principal investigator, National Laboratory Astana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657836
- Sponsor's protocol ID
- AP05135073
- Status last verified
- Feb 2021
- First submitted
- 29 Aug 2018
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valiev AG. [Features of secondary immune response and status of nonspecific resistance of the rat, fed rations with mare's milk, rich in essential fatty acids]. Vopr Pitan. 2001;70(5):10-3. Russian.
PubMed 11715690Pahud JJ, Mach JP. Equine secretory IgA and secretory component. Int Arch Allergy Appl Immunol. 1972;42(2):175-86. doi: 10.1159/000230604. No abstract available.
PubMed 4622991Foekel 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 19462320Wulijideligen, 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 23035710Hancock JT, Salisbury V, Ovejero-Boglione MC, Cherry R, Hoare C, Eisenthal R, Harrison R. Antimicrobial properties of milk: dependence on presence of xanthine oxidase and nitrite. Antimicrob Agents Chemother. 2002 Oct;46(10):3308-10. doi: 10.1128/AAC.46.10.3308-3310.2002.
PubMed 12234868Palmer AC. Nutritionally mediated programming of the developing immune system. Adv Nutr. 2011 Sep;2(5):377-95. doi: 10.3945/an.111.000570. Epub 2011 Sep 6.
PubMed 22332080ADIYAR NURGAZIYEV, YERMEK AITENOV et al. Effect of mare's milk prebiotic supplementation on the gut microbiome and the immune system following antibiotic therapy // B IOD I V E R S I T A S.- Volume 21, Number 11, November 2020 Pages: 5065-5071 DOI: 10.13057/biodiv/d211110
SAMAT KOZHAKHMETOV, DMITRIY BABENKO. The combination of mare's milk and grape polyphenol extract for treatment of dysbiosis induced by dextran sulfate sodium // B IOD I V E R S I T A S Volume 21, Number 5, May 2020 Pages: 2275-2280 DOI: 10.13057/biodiv/d210558
Almagul Kushugulova, Samat Kozhakhmetov. Mare's milk as a prospective functional product //Functional Foods in Health and Disease. = 2018; 8(11): 537-543
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of the Sublimated Mare Milk Supplement in Protection of Gut Mucosal Lining During Antibiotic Treatment
- ClinicalTrials.gov ID
- NCT03657836
- Acronym / sponsor ID
- AP05135073
- Conditions
- Acute Bronchitis
- Keywords
- Acute Bronchitis, Mare milk, Gut mucosa, Antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nazarbayev University Medical CenterUniversity, hospital or other
- Collaborators
- Eurasia Invest Ltd., Ministry of Education and Science, Republic of Kazakhstan
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 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 clinical trial studies the effect of sublimated mare milk supplement on gut microbiome of patients with acute bronchitis.
Detailed description
Food has a significant effect on the health of the body, the relationship between diet and health actualizes the importance of expanding the research of functional products. In mare's milk contains about 40 biological components necessary for the human body: amino acids, fats, enzymes (lysozyme, amylase), microelements (calcium, sodium, potassium, phosphorus, iron, magnesium, copper, iodine, sulfur, cobalt, zinc, bromine) and vitamins (A, C, B1, B2, B6, B12, E, H, PP, beta-carotene, folic acid) in optimally balanced proportions.
A high percentage of nutrients, including vitamins, amino acids, contribute to immunomodulation, increasing the adaptogenic properties of the body. Valiev A demonstrated the effect of the essential fatty acids of mare's milk on immunocompetent cells and non-specific resistance after 6 weeks from the beginning of inclusion in the ration of mare's milk.
Secretory IgA is the main immunoglobulin of mare's milk. The homology of human secretory IgA and mare's was previously demonstrated by cross-reactions using human anti-IgA antiserum.
The mare's milk has a powerful detoxification effect, the mare's microflora neutralizes the effect of mutagens, possesses, replenishes with the necessary complex of nutrients and removes toxins from the body. The milk has a certain degree of antimicrobial effect in relation to opportunistic and pathogenic fungi, bacteria and viruses due to its own microflora.
The mare's milk is rich in active substances, natural enzymes that help regulate intestinal flora, limiting the growth of unwanted bacteria and increasing the growth of bifidobacteria and lactic acid bacteria.
In addition, the composition of mare's milk provided immunoglobulins A, M and G, which act as a marker of those microorganisms that can be pathogenic, which facilitates the protection task.
The high antimicrobial activity of mare's milk is associated with the lysozyme contained in it, immunoglobulins, lactoperoxidase and lactoferrin. Getting into the digestive tract lysozyme has a powerful normalizing effect on the composition of the microbial flora of the mouth and intestines. Lysozyme of breast milk is 100 times more active than lysozyme of cow's milk. It not only inhibits the growth of pathogenic flora, but also promotes the growth of bifidoflora in the intestines of infants.
In the framework of the project, methods for the restoration of the mucos layer of the intestine after antibiotic therapy will be developed. In order to develop the algorithm, preliminary studies will be made of changes in the structure of the intestinal microbiota after antibiotic therapy. Recruiting of patients with infectious / non-infectious pathology is supposed, clinical and laboratory examination, biomaterial sampling during antibiotic therapy, 1-5 days and 1-60 days after completion will be performed. Along with the study of microflora, local immunity studies will be carried out. To study the fundamental foundations, experimental studies will be carried out on laboratory animals. On the basis of the knowledge obtained, an algorithm for the restoration of the mucinous layer of the intestine after antibiotic therapy will be published in the form of methodological recommendations.
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 antibiotics | Experimental | Dietary Supplement: Sublimated mare milk supplement, Drug: Standard antibiotic therapyParticipants will take a supplement of 1 sachet (20 mg) dissolved in 200 ml of warm water (36-37 °C) once a day for 60 days accompanied with the standard antibiotic therapy (cefuroxime and ceftriaxone) up to 7 days. |
| Antibiotics only | Other | Drug: Standard antibiotic therapyParticipants will take the prescribed antibiotic therapy (cefuroxime and ceftriaxone) up to 7 days. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients of both sexes aged 4-5 years
- The voluntary informed consent of the parent to participate in the study
- Established diagnosis of acute upper respiratory tract disease with prescription of antibacterial therapy
- The duration of symptoms of acute upper respiratory tract disease no more than 72 hours
- Lack of prescription of antibacterial drugs in the last 3 months
Key exclusion criteria (6 listed)
- Severe forms of acute infections
- The presence in the history of taking probiotics and antibiotics for three months before admission to hospital
- Presence in the anamnesis of chronic diseases of the digestive tract, and also of any surgeries on the digestive tract
- The presence of severe concomitant diseases of the kidneys, liver, cardiovascular, respiratory and other body systems, cancer, mental and decompensated endocrine diseases, tuberculosis, HIV infection
- Patient involvement in other clinical trials within the last 3 months
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 milk supplementThe dietary supplement consisting of sublimated mare milk packed in single-dose sachet. | Dietary supplement | Dietary supplement and antibiotics |
| Standard antibiotic therapyPatients will be given standard therapy antibiotics cefuroxime and ceftriaxone for up to 7 days period. | Drug | Antibiotics only, Dietary supplement and antibiotics |
Primary outcome
Changes in intestinal microbial composition
Time frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 10, Day 15, Day 20, Day 25, Day 30, Day 35, Day 40, Day 45, Day 50, Day 55, Day 60
Rectal swabs will be taken for further analysis of DNA sequence with MiSeq Reporter PCR Amplicon.
Changes in intestinal immune status biomarkers.
Time frame: Baseline, Day 60
Levels of immune markers (cytokines, secretory Immunoglobulin A, interleukins) will be assessed from stool samples.
4 secondary outcomes
Changes in weight of the patient
Time frame: Baseline, Day 60
Defecation frequency
Time frame: Baseline, up to 60 days
Changes in consistency of stool
Time frame: Baseline, Day 60
Changes in color of stool,
Time frame: Baseline, Day 60
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 8 Feb 2021.
- Background: PubMed 11715690Valiev AG. [Features of secondary immune response and status of nonspecific resistance of the rat, fed rations with mare's milk, rich in essential fatty acids]. Vopr Pitan. 2001;70(5):10-3. Russian.
- Background: PubMed 4622991Pahud JJ, Mach JP. Equine secretory IgA and secretory component. Int Arch Allergy Appl Immunol. 1972;42(2):175-86. doi: 10.1159/000230604. No abstract available.
- 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 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.
- Background: PubMed 12234868Hancock JT, Salisbury V, Ovejero-Boglione MC, Cherry R, Hoare C, Eisenthal R, Harrison R. Antimicrobial properties of milk: dependence on presence of xanthine oxidase and nitrite. Antimicrob Agents Chemother. 2002 Oct;46(10):3308-10. doi: 10.1128/AAC.46.10.3308-3310.2002.
- Background: PubMed 22332080Palmer AC. Nutritionally mediated programming of the developing immune system. Adv Nutr. 2011 Sep;2(5):377-95. doi: 10.3945/an.111.000570. Epub 2011 Sep 6.
- Results publicationADIYAR NURGAZIYEV, YERMEK AITENOV et al. Effect of mare's milk prebiotic supplementation on the gut microbiome and the immune system following antibiotic therapy // B IOD I V E R S I T A S.- Volume 21, Number 11, November 2020 Pages: 5065-5071 DOI: 10.13057/biodiv/d211110
- Results publicationSAMAT KOZHAKHMETOV, DMITRIY BABENKO. The combination of mare's milk and grape polyphenol extract for treatment of dysbiosis induced by dextran sulfate sodium // B IOD I V E R S I T A S Volume 21, Number 5, May 2020 Pages: 2275-2280 DOI: 10.13057/biodiv/d210558
- Results publicationAlmagul Kushugulova, Samat Kozhakhmetov. Mare's milk as a prospective functional product //Functional Foods in Health and Disease. = 2018; 8(11): 537-543
- 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.
Almagul Kushugulova, MD, PhD principal investigator
National Laboratory Astana
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 supplement and Standard antibiotic therapy in people with Acute Bronchitis, run by Nazarbayev University Medical Center 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 5 inclusion and 6 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 8 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?
Changes in intestinal microbial composition (time frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 10, Day 15, Day 20, Day 25, Day 30, Day 35, Day 40, Day 45, Day 50, Day 55, Day 60). The study lists 2 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 NCT03657836, which also lists 9 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 8 Feb 2021.