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

February 3, 2021 updated by: Almagul Kushugulova, Nazarbayev University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary supplement and antibiotics
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.
Dietary supplement: Sublimated mare milk supplement
The dietary supplement consisting of sublimated mare milk packed in single-dose sachet.
Drug: Standard antibiotic therapy
Patients will be given standard therapy antibiotics cefuroxime and ceftriaxone for up to 7 days period.
Other: Antibiotics only
Participants will take the prescribed antibiotic therapy (cefuroxime and ceftriaxone) up to 7 days.
Drug: Standard antibiotic therapy
Patients will be given standard therapy antibiotics cefuroxime and ceftriaxone for up to 7 days period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Time Frame: Baseline, Day 60
Levels of immune markers (cytokines, secretory Immunoglobulin A, interleukins) will be assessed from stool samples.
Baseline, Day 60

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nazarbayev University Medical Center

Collaborators

Eurasia Invest Ltd.
Ministry of Education and Science, Republic of Kazakhstan

Investigators

  • Principal Investigator: Almagul Kushugulova, MD, PhD, National Laboratory Astana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

January 20, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

September 1, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP05135073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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