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NCT Number: NCT05970861

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Almaty House of Veterans

Almaty, 050000, Kazakhstan

About this study

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.

  • 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.
  • According to the results, the effectiveness of Saumal itself regarding these 2 parameters will be evaluated.
  • Develop recommendations and an algorithm for patient management after COVID-19 to prevent complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years and older;
  • Patients in rehabilitation after COVID-19;
  • Signed informed consent;
  • 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

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

Treatment and study plan

Freeze-dried Mare Milk (Saumal)

Dietary Supplement

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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. 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:

    • Physical Component Summary (PCS). Combines the following scales: PF, RP, BP, GH.
    • 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Asfendiyarov Kazakh National Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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