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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-08-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Freeze-dried Mare Milk (Saumal)

Intervention Type 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.

Control Group

Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No