N/A
N=75
Effect of Natural Food on Gut Microbiome and Phospholipid Spectrum of Immune Cells in COVID-19 Patients
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT05970861 ↗Enrolled (actual)
75
Serious AEs
—
Results posted
Feb 2025
Primary outcome: Primary: Gut Microbiome — 51.87; 46.1; 29.43; 29.77 Mean percentages of gut microbiota units — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Freeze-dried Mare Milk (Saumal) (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Asfendiyarov Kazakh National Medical University
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gut Microbiome |
51.87; 46.1; 29.43; 29.77; 6.52; 7.91 | <0.05 sig |
| PRIMARY Antiphospholipid Antibodies |
2.73; 4.45; 1.43; 4.50 | >0.05 |
| PRIMARY Biochemical Blood Analysis (Uric Acid) |
5.56; 7.87 | 0.01 sig |
| PRIMARY Quality of Life Changes |
47.965; 50.797; 49.524; 49.393 | <0.01 sig |
| SECONDARY Biochemical Blood Analysis (ALT) |
31; 35 | — |
| SECONDARY Biochemical Blood Analysis (AST) |
34; 33 | — |
| SECONDARY Biochemical Blood Analysis (Glucose) |
5.4; 5.7 | — |
| SECONDARY Biochemical Blood Analysis (Triacylglycerides) |
1.5; 1.4 | — |
| SECONDARY Biochemical Blood Analysis (Alkaline Phosphatase) |
85; 92 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05970861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.