- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05970861
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study consists of three stages. Stage I. Randomized division of 76 patients under study into a main group of 38 patients receiving Saumal for 4 weeks and a control group of 38 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 and antiphospholipid antibodies).
Stage II. The main group will be given Saumal for four weeks, after which the gut microbiome and antiphospholipid antibodies will be collected from both groups once again. This will allow us to assess the impact of freeze-dried mare's milk on the condition of the gut microbiome and antiphospholipid antibodies.
Stage III. Data analysis.
- Based on the results of gut microbiome sequencing and ELISA (antiphospholipid antibodies) in the main and control groups, we determine the dynamic changes of that parameters during COVID-19 rehabilitation.
- According to the results, the effectiveness of Saumal itself regarding these 2 parameters will be evaluated.
- Develop recommendations and an algorithm for patient management after COVID-19 to prevent complications.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abdugani Musayev, Ph.D., M.D.
- Phone Number: +7 777 2509406
- Email: musaev.dr56@gmail.com
Study Contact Backup
- Name: Vildan Indershiyev
- Phone Number: +7 707 5832221
- Email: vildanindershiyev@gmail.com
Study Locations
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Almaty, Kazakhstan, 050000
- Recruiting
- Kamenskoe Plato
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Contact:
- Turysbekov Kuatzhan, Ph.D.
- Phone Number: +7 (778) 5555239
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years and older;
- Patients in rehabilitation after COVID-19;
- Signed informed consent;
- 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:
- Chronic inflammatory bowel disease;
- Gut microbiota transplantation;
- Chronic pancreatic disease, period of exacerbation;
- Liver cirrhosis, Metavir stage 3-4;
- Any disease in the decompensation stage;
- Neuralgic and psychological disorders that interfere with the study;
- Cancer;
- Non-transportable patients;
- Patients who do not reside in Almaty;
- Patients who have refused to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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 20 grams of dry powder per 200 ml of water, 2 times a day, 30 minutes before the meal, for 4 weeks.
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No Intervention: Control Group
Patients who had suffered from COVID-19 in the six months before the start of the study.
There will be no intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gut Microbiome
Time Frame: 4 weeks
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Intestinal microbiome studies will be performed using the Ion 16S™ Metagenomics Kit and Ion Torrent Next Generation Sequencing (NGS) technology. Creation of libraries for NGS sequencing. The commercial Ion 16S™ 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 Ion 520 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
|
Antiphospholipid antibodies
Time Frame: 4 weeks
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IgG or IgM autoantibodies to cardiolipin, phosphatidyl serine, phosphatidyl-inositol, phosphatidyl acid, and β2-glycoprotein I are determined in human venous blood serum by enzyme immunoassay (ELISA) using the Anti-Phospholipid Screen IgG/IgM kit.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune status changes
Time Frame: 4 weeks
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Levels of immune status markers (Immunoglobulin G, Immunoglobulin M, Immunoglobulin A) will be detected from blood samples.
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4 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Abdugani Musayev, Ph.D., M.D., Asfendiyarov Kazakh National Medical University
Publications and helpful links
General Publications
- 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 and dysfunctional immune responses in patients with COVID-19. Gut. 2021 Apr;70(4):698-706. doi: 10.1136/gutjnl-2020-323020. Epub 2021 Jan 11.
- 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 Hospitalization. Gastroenterology. 2020 Sep;159(3):944-955.e8. doi: 10.1053/j.gastro.2020.05.048. Epub 2020 May 20.
- Romaniuk K., Majszyk-Świątek 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.
- 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 and Management 2020;7(4):605-611.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KazNMU_Saumal_COVID
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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