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

The efficacy of natural foods such as freeze-dried mare's milk (Saumal) in post-COVIDsyndrome therapy has not been studied. The literature review has shown that researchershave focused more on evidence-based medications and less on natural products. Some rawfoods, such as freeze-dried mare's milk, contribute to forming complete immune complexesand have antioxidant, membrane stabilizing, and antiviral effects.The use of Saumal proved its effectiveness in patients suffering from chronic hepatitisC. After 4 weeks of using freeze-dried mare's milk, the biodiversity of the intestinalmicrobiome was increased. The content of bacteria secreting short-chain fatty acids alsoincreased.The study aims to confirm these effects at the gene level in patients who underwentCOVID-19. This study will allow us to develop a highly evidence-based component ofrehabilitation therapy in patients after COVID-19.

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.

Completed
COVID-19

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.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
Kazakhstan
Locations

Almaty House of Veterans
Almaty 1526384, Kazakhstan

Asfendiyarov Kazakh National Medical University
NCT Number
Keywords
Covid-19
Gut microbiome
antiphospholipid antibodies
Rehabilitation
food products
MeSH Terms
COVID-19