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The Sublimated Mare Milk Supplement's Effect on Gut Mucosal Lining After Antibiotics

Primary Purpose

Acute Bronchitis

Status
Completed
Phase
Not Applicable
Locations
Kazakhstan
Study Type
Interventional
Intervention
Sublimated mare milk supplement
Standard antibiotic therapy
Sponsored by
Nazarbayev University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bronchitis focused on measuring Acute Bronchitis, Mare milk, Gut mucosa, Antibiotics

Eligibility Criteria

4 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Dietary supplement and antibiotics

Antibiotics only

Arm Description

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.

Participants will take the prescribed antibiotic therapy (cefuroxime and ceftriaxone) up to 7 days.

Outcomes

Primary Outcome Measures

Changes in intestinal microbial composition
Rectal swabs will be taken for further analysis of DNA sequence with MiSeq Reporter PCR Amplicon.
Changes in intestinal immune status biomarkers.
Levels of immune markers (cytokines, secretory Immunoglobulin A, interleukins) will be assessed from stool samples.

Secondary Outcome Measures

Changes in weight of the patient
Weight will be assessed according to percentile tables
Defecation frequency
Defecation frequency based on patient's/parent's/guardian's reports over period of 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.
Changes in color of stool,
Stool color changes will be assessed based on baseline and final visit (Day 60).

Full Information

First Posted
August 29, 2018
Last Updated
February 3, 2021
Sponsor
Nazarbayev University Medical Center
Collaborators
Eurasia Invest Ltd., Ministry of Education and Science, Republic of Kazakhstan
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1. Study Identification

Unique Protocol Identification Number
NCT03657836
Brief Title
The Sublimated Mare Milk Supplement's Effect on Gut Mucosal Lining After Antibiotics
Official Title
Evaluation of Effectiveness of the Sublimated Mare Milk Supplement in Protection of Gut Mucosal Lining During Antibiotic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 20, 2019 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nazarbayev University Medical Center
Collaborators
Eurasia Invest Ltd., Ministry of Education and Science, Republic of Kazakhstan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchitis
Keywords
Acute Bronchitis, Mare milk, Gut mucosa, Antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary supplement and antibiotics
Arm Type
Experimental
Arm Description
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.
Arm Title
Antibiotics only
Arm Type
Other
Arm Description
Participants will take the prescribed antibiotic therapy (cefuroxime and ceftriaxone) up to 7 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sublimated mare milk supplement
Intervention Description
The dietary supplement consisting of sublimated mare milk packed in single-dose sachet.
Intervention Type
Drug
Intervention Name(s)
Standard antibiotic therapy
Intervention Description
Patients will be given standard therapy antibiotics cefuroxime and ceftriaxone for up to 7 days period.
Primary Outcome Measure Information:
Title
Changes in intestinal microbial composition
Description
Rectal swabs will be taken for further analysis of DNA sequence with MiSeq Reporter PCR Amplicon.
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
Title
Changes in intestinal immune status biomarkers.
Description
Levels of immune markers (cytokines, secretory Immunoglobulin A, interleukins) will be assessed from stool samples.
Time Frame
Baseline, Day 60
Secondary Outcome Measure Information:
Title
Changes in weight of the patient
Description
Weight will be assessed according to percentile tables
Time Frame
Baseline, Day 60
Title
Defecation frequency
Description
Defecation frequency based on patient's/parent's/guardian's reports over period of 60 days
Time Frame
Baseline, up to 60 days
Title
Changes in consistency of stool
Description
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.
Time Frame
Baseline, Day 60
Title
Changes in color of stool,
Description
Stool color changes will be assessed based on baseline and final visit (Day 60).
Time Frame
Baseline, Day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Almagul Kushugulova, MD, PhD
Organizational Affiliation
National Laboratory Astana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center
City
Astana
ZIP/Postal Code
010000
Country
Kazakhstan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11715690
Citation
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.
Results Reference
background
PubMed Identifier
4622991
Citation
Pahud 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.
Results Reference
background
PubMed Identifier
19462320
Citation
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.
Results Reference
background
PubMed Identifier
23035710
Citation
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.
Results Reference
background
PubMed Identifier
12234868
Citation
Hancock 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.
Results Reference
background
PubMed Identifier
22332080
Citation
Palmer 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 Reference
background
Citation
ADIYAR 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 Reference
result
Citation
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
Results Reference
result
Citation
Almagul Kushugulova, Samat Kozhakhmetov. Mare's milk as a prospective functional product //Functional Foods in Health and Disease. = 2018; 8(11): 537-543
Results Reference
result

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The Sublimated Mare Milk Supplement's Effect on Gut Mucosal Lining After Antibiotics

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