Clinical trial NCT05970861: Effect of Natural Food on Gut Microbiome and Phospholipid Spectrum of Immune Cells in COVID-19 Patients
Official title: Effect of Natural Food on Gut Microbiome and Phospholipid Spectrum of Immune Cells in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
gut microbiome
antiphospholipid antibodies
rehabilitation
food products
Lead sponsor: Asfendiyarov Kazakh National Medical University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

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.

Primary outcomes:
measure: Gut Microbiome
timeFrame: 4 weeks
measure: Antiphospholipid Antibodies
timeFrame: 4 weeks
measure: Biochemical Blood Analysis (Uric Acid)
timeFrame: 4 weeks
measure: Quality of Life Changes
timeFrame: 4 weeks
Secondary outcomes:
measure: Biochemical Blood Analysis (ALT)
timeFrame: 4 weeks
measure: Biochemical Blood Analysis (AST)
timeFrame: 4 weeks
measure: Biochemical Blood Analysis (Glucose)
timeFrame: 4 weeks
measure: Biochemical Blood Analysis (Triacylglycerides)
timeFrame: 4 weeks
measure: Biochemical Blood Analysis (Alkaline Phosphatase)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Almaty House of Veterans
Study officials:
affiliation: Asfendiyarov Kazakh National Medical University
name: Ainur Yeshmanova, Ph.D.
role: STUDY_DIRECTOR
affiliation: Asfendiyarov Kazakh National Medical University
name: Nikolay Safonov
role: STUDY_CHAIR
affiliation: Asfendiyarov Kazakh National Medical University
name: Zhannat Nurmakhanova, Ph.D
role: STUDY_CHAIR
affiliation: Asfendiyarov Kazakh National Medical University
name: Zhanar Nurgaliyeva, Ph.D.
role: STUDY_CHAIR
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