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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Group | Experimental | 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. |
|
| Control Group | No Intervention | Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freeze-dried Mare Milk (Saumal) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Antiphospholipid Antibodies | 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. | 4 weeks |
| Biochemical Blood Analysis (Uric Acid) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | 4 weeks |
| Quality of Life Changes | Constructs: Physical Functioning (PF), Role Limitations due to Physical Health (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Limitations due to Emotional Problems (RE), Mental Health (MH). All scale ranges (for any construct): 0 to 100. Higher scores indicate: PF - better physical functioning; RP - fewer role limitations due to physical health; BP - less bodily pain; GH - better perceived general health; VT - greater vitality and less fatigue; SF - better social functioning; RE - fewer role limitations due to emotional problems; MH - better mental health. The SF-36 does not have a single total score but can be summarized using two summary measures:
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Blood Analysis (ALT) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | 4 weeks |
| Biochemical Blood Analysis (AST) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ainur Yeshmanova, Ph.D. | Asfendiyarov Kazakh National Medical University | Study Director |
| Nikolay Safonov | Asfendiyarov Kazakh National Medical University | Study Chair |
| Zhannat Nurmakhanova, Ph.D | Asfendiyarov Kazakh National Medical University | Study Chair |
| Zhanar Nurgaliyeva, Ph.D. | Asfendiyarov Kazakh National Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almaty House of Veterans | Almaty | 050000 | Kazakhstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32442562 | Background | 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. | |
| 33431578 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Control Group | Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | Mean percentages of gut microbiota units | 4 weeks |
|
Any adverse events have not been monitored or evaluated.
Any adverse events have not been monitored or evaluated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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There were three main limitations to the study:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Abdugani Musayev | Asfendiyarov Kazakh National Medical University | +77772509406 | musaev.dr56@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2024 | Oct 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| 4 weeks |
| 4 weeks |
| Biochemical Blood Analysis (Glucose) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | 4 weeks |
| Biochemical Blood Analysis (Triacylglycerides) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | 4 weeks |
| Biochemical Blood Analysis (Alkaline Phosphatase) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | 4 weeks |
| Background |
| 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. |
| Background | 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. |
| Background | 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. |
| Background | 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. |
| BG001 | Control Group | Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Count of Participants | Count of Participants | Participants |
|
| OG001 | Control Group | Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention. |
|
|
|
| Primary | Antiphospholipid Antibodies | 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. | Posted | Mean | Standard Error | U/ml | 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) | Posted | Mean | Standard Error | mg/dL | 4 weeks |
|
|
|
|
| Primary | Quality of Life Changes | Constructs: Physical Functioning (PF), Role Limitations due to Physical Health (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Limitations due to Emotional Problems (RE), Mental Health (MH). All scale ranges (for any construct): 0 to 100. Higher scores indicate: PF - better physical functioning; RP - fewer role limitations due to physical health; BP - less bodily pain; GH - better perceived general health; VT - greater vitality and less fatigue; SF - better social functioning; RE - fewer role limitations due to emotional problems; MH - better mental health. The SF-36 does not have a single total score but can be summarized using two summary measures:
| Posted | Mean | Standard Error | T-score | 4 weeks |
|
|
|
|
| Secondary | Biochemical Blood Analysis (ALT) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | Posted | Mean | Full Range | units per liter (IU/L) | 4 weeks |
|
|
|
| Secondary | Biochemical Blood Analysis (AST) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | Posted | Mean | Full Range | units per liter (IU/L) | 4 weeks |
|
|
|
| Secondary | Biochemical Blood Analysis (Glucose) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | Posted | Mean | Full Range | mmol/L | 4 weeks |
|
|
|
| Secondary | Biochemical Blood Analysis (Triacylglycerides) | This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain) | Posted | Mean | Full Range | mmol/L | 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) | Posted | Mean | Full Range | IU/L | 4 weeks |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Group | Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Null hypothesis: No statistically significant difference exists between the scores on a scale (PCS, MCS) after 2 measurements in the control group.
Alternate hypothesis: Statistically significant difference exists between the scores on a scale (PCS, MCS) after 2 measurements in the control group.
| t-test, 2 sided |
| >0.05 |
| Other |
| Null Hypothesis: The freeze-dried mare's milk does not significantly influence the scores on the scales (PCS, MCS). Alternate Hypothesis: The freeze-dried mare's milk significantly influences the scores on the scales (PCS, MCS). | ANOVA | <0.01 | Other |