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

Asfendiyarov Kazakh National Medical University

Status: Completed

Conditions: COVID-19

Treatments: Dietary Supplement: Freeze-dried Mare Milk (Saumal)

Study type: Interventional

Funder types: Other

Identifiers

NCT05970861

KazNMU_Saumal_COVID

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

75 participants in 2 patient groups

Main Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Freeze-dried Mare Milk (Saumal)

Control Group

No Intervention group

Description:

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