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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970861
• Other study ID #: KazNMU_Saumal_COVID
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: Asfendiyarov Kazakh National Medical University
• Contact: Abdugani Musayev, Ph.D., M.D.
• Phone: +7 777 2509406
• Email: musaev.dr56[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
Kazakhstan	Almaty House of Veterans	Almaty

Sponsors (1)

Lead Sponsor	Collaborator
Asfendiyarov Kazakh National Medical University

Country where clinical trial is conducted

Kazakhstan, 

References & Publications (5)

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

Outcome

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