Effect of Natural Food on Gut Microbiome and Phospholipid Spectrum of Immune Cells in COVID-19 Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Gut Microbiome
Study Overview
Brief 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.
Detailed 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.
- 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.
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
- •Non-transportable patients;
- •Patients who do not reside in Almaty;
- •Patients who have refused to participate in the study.
Outcomes
Primary Outcomes
Gut Microbiome
Time Frame: 4 weeks
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.
Antiphospholipid Antibodies
Time Frame: 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.
Biochemical Blood Analysis (Uric Acid)
Time Frame: 4 weeks
This biochemical indicator will be determined from patient serum on a BA400 analyzer (BioSystems S.A., Spain)
Quality of Life Changes
Time Frame: 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)
Secondary Outcomes
- Biochemical Blood Analysis (ALT)(4 weeks)
- Biochemical Blood Analysis (AST)(4 weeks)
- Biochemical Blood Analysis (Glucose)(4 weeks)
- Biochemical Blood Analysis (Triacylglycerides)(4 weeks)
- Biochemical Blood Analysis (Alkaline Phosphatase)(4 weeks)
Investigators
Vildan Indershiyev
Ph.D. candidate
Asfendiyarov Kazakh National Medical University