COVID-19 Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | August 30, 2024 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Kazakhstan | Almaty House of Veterans | Almaty |
Lead Sponsor | Collaborator |
---|---|
Asfendiyarov Kazakh National Medical University |
Kazakhstan,
Kushugulova A., Kozhakhmetov S., Sattybayeva R., Nurgozhina A., Ziyat A., Yadav H., Marotta F. Mare's milk as a prospective functional product. Funct. Food Health Dis. 2018;8:537-543. doi: 10.31989/ffhd.v8i11.528.
Musayev, A., Yeshmanova, A., Pakhomenko, Y., Kozhakhmetov, S.S., Kushugulova, A.K. Effects of Environmental Pollutants on Intestinal Microbiome Under the Influence Of Mare's Milk In Patients with Hepatitis C. Procedia Environmental Science, Engineering an
Romaniuk K., Majszyk-Swiatek M., Kryszak K., Danielewicz A., Andraszek K. Alternative use of mare milk. Folia Pomer. Univ. Technol. Stetin. 2019;348:121-130. doi: 10.21005/AAPZ2019.49.1.13.
Yeoh YK, Zuo T, Lui GC, Zhang F, Liu Q, Li AY, Chung AC, Cheung CP, Tso EY, Fung KS, Chan V, Ling L, Joynt G, Hui DS, Chow KM, Ng SSS, Li TC, Ng RW, Yip TC, Wong GL, Chan FK, Wong CK, Chan PK, Ng SC. Gut microbiota composition reflects disease severity an — View Citation
Zuo T, Zhang F, Lui GCY, Yeoh YK, Li AYL, Zhan H, Wan Y, Chung ACK, Cheung CP, Chen N, Lai CKC, Chen Z, Tso EYK, Fung KSC, Chan V, Ling L, Joynt G, Hui DSC, Chan FKL, Chan PKS, Ng SC. Alterations in Gut Microbiota of Patients With COVID-19 During Time of — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gut Microbiome | 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. | 4 weeks | |
Primary | Antiphospholipid antibodies | IgG or IgM autoantibodies to cardiolipin, phosphatidyl serine, phosphatidyl-inositol, phosphatidyl acid, and ß2-glycoprotein I are determined in human venous blood serum by enzyme immunoassay (ELISA) using the Anti-Phospholipid Screen IgG/IgM kit. | 4 weeks | |
Primary | Biochemical blood analysis (uric acid) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | 4 weeks | |
Secondary | Immune status changes | Levels of immune status markers (Immunoglobulin G, Immunoglobulin M, Immunoglobulin A) will be detected from blood samples. | 4 weeks | |
Secondary | Biochemical blood analysis (ALT) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | 4 weeks | |
Secondary | Biochemical blood analysis (AST) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | 4 weeks | |
Secondary | Biochemical blood analysis (glucose) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | 4 weeks | |
Secondary | Biochemical blood analysis (triacylglycerides) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | 4 weeks | |
Secondary | Biochemical blood analysis (alkaline phosphatase) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | 4 weeks |
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