Effect of Natural Food on Gut Microbiome and Phospholipid Spectrum of Immune Cells in COVID-19 Patients

January 11, 2025 updated by: Vildan Indershiyev, Asfendiyarov Kazakh National Medical University

The efficacy of natural foods such as freeze-dried mare's milk (Saumal) in post-COVID syndrome therapy has not been studied. The literature review has shown that researchers have focused more on evidence-based medications and less on natural products. Some raw foods, such as freeze-dried mare's milk, contribute to forming complete immune complexes and have antioxidant, membrane stabilizing, and antiviral effects.

The use of Saumal proved its effectiveness in patients suffering from chronic hepatitis C. After 4 weeks of using freeze-dried mare's milk, the biodiversity of the intestinal microbiome was increased. The content of bacteria secreting short-chain fatty acids also increased.

The study aims to confirm these effects at the gene level in patients who underwent COVID-19. This study will allow us to develop a highly evidence-based component of rehabilitation therapy in patients after COVID-19.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study consists of three stages. Stage I. Randomized division of 75 patients under study into a main group of 38 patients receiving Saumal for 4 weeks and a control group of 37 patients not receiving Saumal. All respondents have suffered from COVID-19 in the last 6 months. At the moment of the research, all patients will be staying in rehabilitation centers in Almaty City.

The study's biological material will be collected from the respondents (gut microbiome, antiphospholipid antibodies, biochemical blood analysis (glucose, ALT, AST, uric acid, TAGs, alkaline phosphatase)).

Stage II. The main group will be given Saumal for four weeks, after which the gut microbiome, antiphospholipid antibodies, and biochemical blood analysis will be collected from both groups again. This will allow us to assess the impact of freeze-dried mare's milk on the condition of the gut microbiome, antiphospholipid antibodies, and biochemical blood analysis.

Stage III. Data analysis.

  1. Based on the results of gut microbiome sequencing, ELISA (antiphospholipid antibodies), and biochemical blood analysis in the main and control groups, we determine the dynamic changes of those parameters during COVID-19 rehabilitation.
  2. According to the results, the effectiveness of Saumal itself regarding these 2 parameters will be evaluated.
  3. Develop recommendations and an algorithm for patient management after COVID-19 to prevent complications.

Study Type

Interventional

Enrollment (Actual)

75

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
      • Almaty, Kazakhstan, 050000
        • Almaty House of Veterans

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 years and older;
  2. Patients in rehabilitation after COVID-19;
  3. Signed informed consent;
  4. Presence of patient's history of COVID-19, reliably established by PCR+ /presence of IgG/ diagnosis of coronavirus pneumonia on Computer Tomography based on discharge from hospital or outpatient records.

Exclusion Criteria:

  1. Chronic inflammatory bowel disease;
  2. Gut microbiota transplantation;
  3. Chronic pancreatic disease, period of exacerbation;
  4. Liver cirrhosis, Metavir stage 3-4;
  5. Any disease in the decompensation stage;
  6. Neuralgic and psychological disorders that interfere with the study;
  7. Cancer;
  8. Non-transportable patients;
  9. Patients who do not reside in Almaty;
  10. Patients who have refused to participate in the study.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Main Group
Patients who had suffered from COVID-19 in the six months before the start of the study. Patients will receive Saumal (freeze-dried mare milk) for four weeks.
Dietary supplement: Freeze-dried Mare Milk (Saumal)
Freeze-dried Mare Milk (Saumal) is frequently reported for having therapeutic and dietary properties associated with specific chemical composition and certain physical properties of the product. It contains a total of about 40 biologically active components, the most important of them vitamins A, C, B1, B2, B6, and B12, amino acids, enzymes, and trace elements (low molecular weight peptides, lactalbumins, and globulins). Saumal will be administered to patients at a dose of 25 grams of dry powder per 200 ml of water, 2 times a day, 30 minutes before the meal, for 4 weeks.
No Intervention: Control Group
Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut Microbiome
Time Frame: 4 weeks
Intestinal microbiome studies will be performed using the Illumina MiSeq Metagenomics Kit. Creation of libraries for NGS sequencing. The commercial Illumina MiSeq The Metagenomics Kit includes two primer pools that can amplify the hypervariable regions of 16S rRNA in bacteria. The first pool produces V2-4-8, while the second pool allows for the production of V3-6 and 7-9 regions of 16S rRNA. Sequencing will be performed on an Ion S5 analyzer using an Illumina MiSeq Chip Kit. Once the PCR products have been run, it is important to follow standard procedures for fragment end recovery, adaptor ligation, nick gap repair, qualitative and quantitative assessment of non-amplified libraries, and pooling.
4 weeks
Antiphospholipid Antibodies
Time Frame: 4 weeks
IgG or IgM autoantibodies to cardiolipin, phosphatidyl serine, phosphatidyl-inositol, phosphatidyl acid, and β2-glycoprotein I are determined in human venous blood serum by enzyme immunoassay (ELISA) using the Anti-Phospholipid Screen IgG/IgM kit.
4 weeks
Biochemical Blood Analysis (Uric Acid)
Time Frame: 4 weeks
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
4 weeks
Quality of Life Changes
Time Frame: 4 weeks

Constructs: Physical Functioning (PF), Role Limitations due to Physical Health (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Limitations due to Emotional Problems (RE), Mental Health (MH). All scale ranges (for any construct): 0 to 100.

Higher scores indicate: PF - better physical functioning; RP - fewer role limitations due to physical health; BP - less bodily pain; GH - better perceived general health; VT - greater vitality and less fatigue; SF - better social functioning; RE - fewer role limitations due to emotional problems; MH - better mental health.

The SF-36 does not have a single total score but can be summarized using two summary measures:

  1. Physical Component Summary (PCS). Combines the following scales: PF, RP, BP, GH.
  2. Mental Component Summary (MCS). Combines the following scales: VT, SF, RE, MH. Higher scores indicate better physical and mental health. Range: Typically standardized (mean = 50, SD = 10)
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Blood Analysis (ALT)
Time Frame: 4 weeks
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
4 weeks
Biochemical Blood Analysis (AST)
Time Frame: 4 weeks
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
4 weeks
Biochemical Blood Analysis (Glucose)
Time Frame: 4 weeks
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
4 weeks
Biochemical Blood Analysis (Triacylglycerides)
Time Frame: 4 weeks
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
4 weeks
Biochemical Blood Analysis (Alkaline Phosphatase)
Time Frame: 4 weeks
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
4 weeks

Collaborators and Investigators

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

Sponsor

Asfendiyarov Kazakh National Medical University

Investigators

  • Study Director: Ainur Yeshmanova, Ph.D., Asfendiyarov Kazakh National Medical University
  • Study Chair: Nikolay Safonov, Asfendiyarov Kazakh National Medical University
  • Study Chair: Zhannat Nurmakhanova, Ph.D, Asfendiyarov Kazakh National Medical University
  • Study Chair: Zhanar Nurgaliyeva, Ph.D., Asfendiyarov Kazakh National Medical University

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)

September 1, 2023

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 11, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KazNMU_Saumal_COVID

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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