Effect of Natural Food on Gut Microbiome and Phospholipid Spectrum of Immune Cells in COVID-19 Patients

NCT05970861 | Completed Results

• 1 other identifier: KazNMU_Saumal_COVID
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; gut microbiome; antiphospholipid antibodies; rehabilitation; food products

Outcome Measures

Primary Outcomes (4)

• 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: 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)

  4 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

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.

Dietary Supplement: Freeze-dried Mare Milk (Saumal)

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.

Interventions

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.

Main Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asfendiyarov Kazakh National Medical University: lead

Study Sites (1)

Almaty House of Veterans

Almaty, 050000, Kazakhstan

Location

Related Publications (5)

• 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.

  PMID: 32442562 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.

  PMID: 33431578 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.

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

There were three main limitations to the study: 1. A significant amount of time has passed since the patients had COVID-19. 2. During the analysis of antiphospholipid antibody levels, we found that screening kits were used. 3. The severity of COVID-19 was not considered as an inclusion criterion.

Results Point of Contact

• Title: Prof. Abdugani Musayev
• Organization: Asfendiyarov Kazakh National Medical University

musaev.dr56@gmail.com

+77772509406

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. candidate

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 1, 2023
• Study Start: September 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-01

Locations

KA (1)