Trial Outcomes & Findings for Effect of Natural Food on Gut Microbiome and Phospholipid Spectrum of Immune Cells in COVID-19 Patients (NCT NCT05970861)

Last Updated: 2025-02-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

75 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Control Group Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.
Overall Study STARTED	38	37
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Control Group Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.
Overall Study Physician Decision	4	4
Overall Study Lost to Follow-up	4	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Main Group n=30 Participants 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.	Control Group n=30 Participants Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=30 Participants	20 Participants n=30 Participants	40 Participants n=60 Participants
Age, Categorical >=65 years	10 Participants n=30 Participants	10 Participants n=30 Participants	20 Participants n=60 Participants
Sex: Female, Male Female	20 Participants n=30 Participants	20 Participants n=30 Participants	40 Participants n=60 Participants
Sex: Female, Male Male	10 Participants n=30 Participants	10 Participants n=30 Participants	20 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Count of Participants	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

PRIMARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Main Group n=30 Participants 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.	Control Group n=30 Participants Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.
Antiphospholipid Antibodies IgM	2.73 U/ml Standard Error 0.185	4.45 U/ml Standard Error 0.001
Antiphospholipid Antibodies IgG	1.43 U/ml Standard Error 0.726	4.50 U/ml Standard Error 0.0001

PRIMARY outcome

Timeframe: 4 weeks

This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)

Outcome measures

Outcome measures
Measure	Main Group n=30 Participants 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.	Control Group n=30 Participants Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.
Biochemical Blood Analysis (Uric Acid)	5.56 mg/dL Standard Error 0.01	7.87 mg/dL Standard Error 0.34

PRIMARY outcome

Timeframe: 4 weeks

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: 1. Physical Component Summary (PCS). Combines the following scales: PF, RP, BP, GH. 2. Mental Component Summary (MCS). Combines the following scales: VT, SF, RE, MH. Higher scores indicate better physical and mental health. Range: Typically standardized (mean = 50, SD = 10)

Outcome measures

Outcome measures
Measure	Main Group n=30 Participants 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.	Control Group n=30 Participants Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.
Quality of Life Changes MCS	49.524 T-score Standard Error 0.001	49.393 T-score Standard Error 0.091
Quality of Life Changes PCS	47.965 T-score Standard Error 0.004	50.797 T-score Standard Error 0.647

SECONDARY outcome

Timeframe: 4 weeks

This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)

Outcome measures

Outcome measures
Measure	Main Group n=30 Participants 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.	Control Group n=30 Participants Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.
Biochemical Blood Analysis (ALT)	31 units per liter (IU/L) Interval 25.0 to 37.0	35 units per liter (IU/L) Interval 23.0 to 47.0

SECONDARY outcome

Timeframe: 4 weeks

This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)

Outcome measures

Outcome measures
Measure	Main Group n=30 Participants 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.	Control Group n=30 Participants Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.
Biochemical Blood Analysis (AST)	34 units per liter (IU/L) Interval 25.0 to 43.0	33 units per liter (IU/L) Interval 27.0 to 39.0

SECONDARY outcome

Timeframe: 4 weeks

This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)

Outcome measures

Outcome measures
Measure	Main Group n=30 Participants 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.	Control Group n=30 Participants Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.
Biochemical Blood Analysis (Glucose)	5.4 mmol/L Interval 4.2 to 6.6	5.7 mmol/L Interval 3.8 to 7.6

SECONDARY outcome

Timeframe: 4 weeks

This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)

Outcome measures

Outcome measures
Measure	Main Group n=30 Participants 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.	Control Group n=30 Participants Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.
Biochemical Blood Analysis (Triacylglycerides)	1.5 mmol/L Interval 1.3 to 1.7	1.4 mmol/L Interval 1.2 to 1.6

SECONDARY outcome

Timeframe: 4 weeks

This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)

Outcome measures

Outcome measures
Measure	Main Group n=30 Participants 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.	Control Group n=30 Participants Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.
Biochemical Blood Analysis (Alkaline Phosphatase)	85 IU/L Interval 65.0 to 105.0	92 IU/L Interval 70.0 to 114.0

Adverse Events

Main Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Abdugani Musayev

Asfendiyarov Kazakh National Medical University

Phone: +77772509406

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Main Group n=30 Participants 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.	Control Group n=30 Participants Patients who had suffered from COVID-19 in the six months before the start of the study. There will be no intervention.
Gut Microbiome Percentage of "Firmicutes" phylum at 4 weeks	51.87 Mean percentages of gut microbiota units Standard Error 0.001	46.1 Mean percentages of gut microbiota units Standard Error 0.899
Gut Microbiome Percentage of "Proteobacteria" phylum at 4 weeks	6.52 Mean percentages of gut microbiota units Standard Error 0.00001	7.91 Mean percentages of gut microbiota units Standard Error 0.823
Gut Microbiome Percentage of "Actinobacteria" phylum at 4 weeks	4.9 Mean percentages of gut microbiota units Standard Error 0.951	9.36 Mean percentages of gut microbiota units Standard Error 0.003
Gut Microbiome Percentage of "Bacilli" class at 4 weeks	4.02 Mean percentages of gut microbiota units Standard Error 0.043	4.46 Mean percentages of gut microbiota units Standard Error 0.068
Gut Microbiome Percentage of "Deltaproteobacteria" class at 4 weeks	0.94 Mean percentages of gut microbiota units Standard Error 0.048	0.92 Mean percentages of gut microbiota units Standard Error 0.918
Gut Microbiome Percentage of "Erysipelotrichi" class at 4 weeks	1.58 Mean percentages of gut microbiota units Standard Error 0.012	1.46 Mean percentages of gut microbiota units Standard Error 0.889
Gut Microbiome Percentage of "Caldilinea" genus at 4 weeks	0.06 Mean percentages of gut microbiota units Standard Error 0.014	0.17 Mean percentages of gut microbiota units Standard Error 0.345
Gut Microbiome Percentage of "Clostridium" genus at 4 weeks	5.07 Mean percentages of gut microbiota units Standard Error 0.008	2.59 Mean percentages of gut microbiota units Standard Error 0.893
Gut Microbiome Percentage of "Lachnospira" genus at 4 weeks	1.77 Mean percentages of gut microbiota units Standard Error 0.004	1.76 Mean percentages of gut microbiota units Standard Error 0.049
Gut Microbiome Percentage of "Prevotella" genus at 4 weeks	8.85 Mean percentages of gut microbiota units Standard Error 0.003	11.24 Mean percentages of gut microbiota units Standard Error 0.698
Gut Microbiome Percentage of "Tindallia" genus at 4 weeks	0.20 Mean percentages of gut microbiota units Standard Error 0.02	0.00 Mean percentages of gut microbiota units Standard Error 1.00
Gut Microbiome Percentage of "Alkaliphilus crotonatoxidans" species at 4 weeks	1.40 Mean percentages of gut microbiota units Standard Error 0.00001	0.93 Mean percentages of gut microbiota units Standard Error 0.028
Gut Microbiome Percentage of "Bacteroides xylanisolvens" species at 4 weeks	1.30 Mean percentages of gut microbiota units Standard Error 0.00001	1.63 Mean percentages of gut microbiota units Standard Error 0.245
Gut Microbiome Percentage of "Bifidobacterium catenulatum" species at 4 weeks	0.96 Mean percentages of gut microbiota units Standard Error 0.024	1.68 Mean percentages of gut microbiota units Standard Error 0.434
Gut Microbiome Percentage of "Bifidobacterium indicum" species at 4 weeks	0.10 Mean percentages of gut microbiota units Standard Error 0.026	0.20 Mean percentages of gut microbiota units Standard Error 0.052
Gut Microbiome Percentage of "Roseburia faecis" species at 4 weeks	0.72 Mean percentages of gut microbiota units Standard Error 0.006	0.36 Mean percentages of gut microbiota units Standard Error 0.551
Gut Microbiome Percentage of "Bacteroides" phylum at 4 weeks	29.43 Mean percentages of gut microbiota units Standard Error 0.178	29.77 Mean percentages of gut microbiota units Standard Error 0.754
Gut Microbiome Percentage of "Desulfovibrio" genus at 4 weeks	0.19 Mean percentages of gut microbiota units Standard Error 0.039	0.76 Mean percentages of gut microbiota units Standard Error 0.008
Gut Microbiome Percentage of "Escherichia" genus at 4 weeks	0.75 Mean percentages of gut microbiota units Standard Error 0.042	1.2 Mean percentages of gut microbiota units Standard Error 0.710
Gut Microbiome Percentage of "Anaerobranca zavarzinii" species at 4 weeks	0.62 Mean percentages of gut microbiota units Standard Error 0.006	0.18 Mean percentages of gut microbiota units Standard Error 0.004