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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
161
1 \* 10\^8 CFU of L. reuteri DSM 17938 + 10 ug vitamin D3, two capsules per day for 6 months
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
Örebro University
Örebro, Örebro County, Sweden
SARS-CoV-2 specific antibodies
Change in SARS-CoV-2 specific IgG/IgM antibodies in serum between the study arms
Time frame: 3 months (interim analysis) or at 6 months
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
Time frame: 3 months + 6 months
Duration of COVID-19 symptoms measured by a weekly symptom questionnaire
Change in duration of COVID-19 related symptoms between the study arms
Time frame: 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
Time frame: 3 months + 6 months
Secretory IgA (sIgA) antibodies
Change in sIgA levels in saliva between the study arms
Time frame: 3 months + 6 months
Blood group A antigen antibodies
Change in anti-A levels in serum between the study arms
Time frame: 3 months + 6 months
Blood group B antigen antibodies
Change in anti-B levels in serum between the study arms
Time frame: 3 months + 6 months
Tn antigen antibodies
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Change in anti-Tn levels in serum between the study arms
Time frame: 3 months + 6 months
Innate immune system activation
Change in high-sensitive C-reactive protein (hs-CRP) levels in plasma between the study groups
Time frame: 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
Time frame: 3 months + 6 months
Total antibodies
Change in total IgG and IgM levels in serum between the study groups
Time frame: 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
Time frame: 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
Time frame: 3 months + 6 months
Intestinal inflammation
Change in faecal calprotectin levels between the study arms
Time frame: 3 months + 6 months
Intestinal barrier function
Change in I-FABP levels in plasma between the study arms
Time frame: 3 months + 6 months
Indirect marker of intestinal permeability
Change in LBP levels in plasma between the study arms
Time frame: 3 months + 6 months