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| Name | Class |
|---|---|
| BioGaia AB | INDUSTRY |
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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.
After giving their informed consent, the study subjects will complete screening procedures to assess their eligibility for the study (Visit 1). Participants deemed suitable for the study will be randomized into two study arms (placebo, probiotic) before undergoing a baseline visit (Visit 2) before the start of the intervention period. During the 6-month intervention period, the participants will attend study visits at 3 months (Visit 3) into the intervention as well as at the end of intervention (at 6 months, Visit 4). Blood, saliva, and faecal samples will be collected at visits 2-4. In addition to sampling, during the whole intervention period, the participants will fill out a weekly questionnaire in which they are asked to record any possible symptoms of COVID-19. The participants' dietary habits are assessed via a food frequency questionnaire (FFQ) before the start of the intervention period. Also, the participants are asked to maintain their habitual diet and lifestyle as well as not to consume any other probiotic or prebiotic supplements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L. reuteri DSM 17938 | Active Comparator | Probiotic compound |
|
| Placebo | Placebo Comparator | Placebo compound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L. reuteri DSM 17938 + vitamin D | Dietary Supplement | 1 * 10^8 CFU of L. reuteri DSM 17938 + 10 ug vitamin D3, two capsules per day for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Duration of COVID-19 symptoms measured by a weekly symptom questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Composition of intestinal microbiota and SARS-CoV-2 specific antibody |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Brummer, MD, PhD | Örebro University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro University | Örebro | Örebro County | 703 62 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24638909 | Background | Lehtoranta L, Pitkaranta 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. | |
| 28923425 | Background | 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. |
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IPD will not be shared, results will shared only on group-level
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo + vitamin D | Dietary Supplement | Placebo tablet + 10 ug vitamin D3, Similar in shape and taste to intervention capsules but without the probiotic components, two capsules per day over six weeks |
|
Change in duration of COVID-19 related symptoms between the study arms |
| 3 months + 6 months |
| 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 |
| Secretory IgA (sIgA) antibodies | Change in sIgA levels in saliva between the study arms | 3 months + 6 months |
| Blood group A antigen antibodies | Change in anti-A levels in serum between the study arms | 3 months + 6 months |
| Blood group B antigen antibodies | Change in anti-B levels in serum between the study arms | 3 months + 6 months |
| Tn antigen antibodies | Change in anti-Tn levels in serum between the study arms | 3 months + 6 months |
| Innate immune system activation | Change in high-sensitive C-reactive protein (hs-CRP) levels in plasma between the study groups | 3 months + 6 months |
| 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 |
| Total antibodies | Change in total IgG and IgM levels in serum between the study groups | 3 months + 6 months |
| 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 |
| 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 |
| Intestinal inflammation | Change in faecal calprotectin levels between the study arms | 3 months + 6 months |
| Intestinal barrier function | Change in I-FABP levels in plasma between the study arms | 3 months + 6 months |
| Indirect marker of intestinal permeability | Change in LBP levels in plasma between the study arms | 3 months + 6 months |
Correlation of intestinal microbiota composition to SARS-CoV-2 specific antibody levels in serum |
| 3 months + 6 months |
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |