Covid19 Clinical Trial
Official title:
Exploratory Study on the Effects of Probiotic Supplementation on SARS-CoV-2 Antibody Response in Healthy Adults
Verified date | September 2021 |
Source | Örebro University, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will explore how a well-known probiotic strain L. reuteri DSM 17938 impacts SARS-CoV-2 specific antibody response upon and after infection in healthy adults.
Status | Completed |
Enrollment | 161 |
Est. completion date | September 13, 2021 |
Est. primary completion date | September 13, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Signed informed consent 2. Age between 18-60 Exclusion Criteria: 1. Previous diagnosis of COVID-19 (by positive PCR) or previous confirmation of seropositivity to SARS-CoV-2 2. Body Mass Index over 35 or under 16 3. Current diagnosis of cancer or ongoing cancer treatment in the last 12 months 4. Diabetes mellitus 5. Cardiovascular disorder in need of pharmaceutical treatment 6. Chronic kidney disease 7. Chronic lung disease with decreased lung capacity 8. Chronic liver disease with liver cirrhosis 9. Current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation 10. Chronic neurological/neurodegenerative disease (e.g. Parkinson's disease) 11. Decreased function of the adrenal cortex (e.g. Addison's disease) 12. Autoimmune disease (e.g. rheumatoid arthritis) 13. Chronic pain syndromes (e.g. fibromyalgia) 14. Pregnancy or breast-feeding 15. Immunodeficiency due to disease or ongoing medical treatment 16. Regular intake of anti-inflammatory and/or other immunosuppressive medication within the last 3 months 17. Use of anti-depressants within the last 3 months 18. Antimicrobial treatment within the last 12 weeks before baseline sampling 19. Regular intake of probiotics, as well as nutritional supplements or herb products that might affect intestinal function within the last 4 weeks if the investigator considers that those could affect study outcome 20. Inability to maintain current diet and lifestyle during the study period 21. Alcohol or drug abuse 22. Any clinically significant present or past disease/condition which the investigator considers to possibly interfere with the study outcome or increase the risk for severe form of COVID-19 |
Country | Name | City | State |
---|---|---|---|
Sweden | Örebro University | Örebro | Örebro Län |
Lead Sponsor | Collaborator |
---|---|
Örebro University, Sweden | BioGaia AB |
Sweden,
Lehtoranta L, Pitkäranta A, Korpela R. Probiotics in respiratory virus infections. Eur J Clin Microbiol Infect Dis. 2014 Aug;33(8):1289-302. doi: 10.1007/s10096-014-2086-y. Epub 2014 Mar 18. Review. — View Citation
Zimmermann P, Curtis N. The influence of probiotics on vaccine responses - A systematic review. Vaccine. 2018 Jan 4;36(2):207-213. doi: 10.1016/j.vaccine.2017.08.069. Epub 2017 Sep 18. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Composition of intestinal microbiota and COVID-19 related symptoms | Correlation of intestinal microbiota composition to duration and severity of COVID-19 related symptoms | 3 months + 6 months | |
Other | Composition of intestinal microbiota and SARS-CoV-2 specific antibody | Correlation of intestinal microbiota composition to SARS-CoV-2 specific antibody levels in serum | 3 months + 6 months | |
Other | Composition of intestinal microbiota and inflammatory profile | Correlation of intestinal microbiota composition to TNF-a, IFN-y, IL-1B, IL-4, IL-6, IL-8, IL-10 levels in serum | 3 months + 6 months | |
Primary | SARS-CoV-2 specific antibodies | Change in SARS-CoV-2 specific IgG/IgM antibodies in serum between the study arms | 3 months (interim analysis) or at 6 months | |
Secondary | Maintenance of SARS-CoV-2 seroconversion in seropositive individuals | Change in the maintenance of SARS-CoV-2 specific IgG/IgM antibody levels in serum between the study arms | 3 months + 6 months | |
Secondary | Duration of COVID-19 symptoms measured by a weekly symptom questionnaire | Change in duration of COVID-19 related symptoms between the study arms | 3 months + 6 months | |
Secondary | Severity of COVID-19 symptoms measured by Ordinal Scale for Clinical Improvement (scale 0-7, a lower score corresponds to a better outcome) | Change in severity of COVID-19 related symptoms between the study arms | 3 months + 6 months | |
Secondary | Secretory IgA (sIgA) antibodies | Change in sIgA levels in saliva between the study arms | 3 months + 6 months | |
Secondary | Blood group A antigen antibodies | Change in anti-A levels in serum between the study arms | 3 months + 6 months | |
Secondary | Blood group B antigen antibodies | Change in anti-B levels in serum between the study arms | 3 months + 6 months | |
Secondary | Tn antigen antibodies | Change in anti-Tn levels in serum between the study arms | 3 months + 6 months | |
Secondary | Innate immune system activation | Change in high-sensitive C-reactive protein (hs-CRP) levels in plasma between the study groups | 3 months + 6 months | |
Secondary | Cytokines | Change in TNF-a, IFN-y, IL-1B, IL-4, IL-6, IL-8, IL-10 levels in serum between the study groups | 3 months + 6 months | |
Secondary | Total antibodies | Change in total IgG and IgM levels in serum between the study groups | 3 months + 6 months | |
Secondary | T cell activation | Change in the proportion of SARS-CoV-2 specific T cells of all T cells in blood between the study arms | 3 months + 6 months | |
Secondary | B cell activation | Change in the proportion of SARS-CoV-2 specific B cells of all B cells in blood between the study arms | 3 months + 6 months | |
Secondary | Intestinal inflammation | Change in faecal calprotectin levels between the study arms | 3 months + 6 months | |
Secondary | Intestinal barrier function | Change in I-FABP levels in plasma between the study arms | 3 months + 6 months | |
Secondary | Indirect marker of intestinal permeability | Change in LBP levels in plasma between the study arms | 3 months + 6 months |
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