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

NCT03657836 | Completed

• 1 other identifier: AP05135073
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies the effect of sublimated mare milk supplement on gut microbiome of patients with acute bronchitis.

Conditions

Acute Bronchitis

Keywords

Acute Bronchitis; Mare milk; Gut mucosa; Antibiotics

Outcome Measures

Primary Outcomes (2)

• Changes in intestinal microbial composition

  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.

  Levels of immune markers (cytokines, secretory Immunoglobulin A, interleukins) will be assessed from stool samples.

  Baseline, Day 60

Secondary Outcomes (4)

• Changes in weight of the patient

  Baseline, Day 60

• Defecation frequency

  Baseline, up to 60 days

• Changes in consistency of stool

  Baseline, Day 60

• Changes in color of stool,

  Baseline, Day 60

Study Arms (2)

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.

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.

Drug: Standard antibiotic therapy

Interventions

Sublimated mare milk supplement DIETARY_SUPPLEMENT

The dietary supplement consisting of sublimated mare milk packed in single-dose sachet.

Dietary supplement and antibiotics

Standard antibiotic therapy DRUG

Patients will be given standard therapy antibiotics cefuroxime and ceftriaxone for up to 7 days period.

Antibiotics only; Dietary supplement and antibiotics

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nazarbayev University Medical Center: lead
• Eurasia Invest Ltd.: collaborator
• Ministry of Education and Science, Republic of Kazakhstan: collaborator

Study Sites (1)

University Medical Center

Astana, 010000, Kazakhstan

Location

Related Publications (9)

• 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.

  PMID: 11715690 BACKGROUND

• 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.

  PMID: 4622991 BACKGROUND

• 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.

  PMID: 19462320 BACKGROUND

• 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.

  PMID: 23035710 BACKGROUND

• 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.

  PMID: 12234868 BACKGROUND

• 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.

  PMID: 22332080 BACKGROUND

• 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

  RESULT

• 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

  RESULT

• Almagul Kushugulova, Samat Kozhakhmetov. Mare's milk as a prospective functional product //Functional Foods in Health and Disease. = 2018; 8(11): 537-543

  RESULT

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Almagul Kushugulova, MD, PhD

  National Laboratory Astana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Laboratory of Human Microbiome and Longevity

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 5, 2018
• Study Start: August 1, 2018
• Primary Completion: January 20, 2019
• Study Completion: December 1, 2020
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)