Örebro University
Örebro, Örebro County, 703 62, Sweden
NCT Number: NCT04734886
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Örebro, Örebro County, 703 62, Sweden
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 3 months (interim analysis) or at 6 months
Change in SARS-CoV-2 specific IgG/IgM antibodies in serum between the study arms
Time frame: 3 months + 6 months
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
Change in duration of COVID-19 related symptoms between the study arms
Time frame: 3 months + 6 months
Change in severity of COVID-19 related symptoms between the study arms
Time frame: 3 months + 6 months
Change in sIgA levels in saliva between the study arms
Time frame: 3 months + 6 months
Change in anti-A levels in serum between the study arms
Time frame: 3 months + 6 months
Change in anti-B levels in serum between the study arms
Time frame: 3 months + 6 months
Change in anti-Tn levels in serum between the study arms
Time frame: 3 months + 6 months
Change in high-sensitive C-reactive protein (hs-CRP) levels in plasma between the study groups
Time frame: 3 months + 6 months
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
Change in total IgG and IgM levels in serum between the study groups
Time frame: 3 months + 6 months
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
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
Change in faecal calprotectin levels between the study arms
Time frame: 3 months + 6 months
Change in I-FABP levels in plasma between the study arms
Time frame: 3 months + 6 months
Change in LBP levels in plasma between the study arms
Time frame: 3 months + 6 months
Correlation of intestinal microbiota composition to duration and severity of COVID-19 related symptoms
Time frame: 3 months + 6 months
Correlation of intestinal microbiota composition to SARS-CoV-2 specific antibody levels in serum
Time frame: 3 months + 6 months
Correlation of intestinal microbiota composition to TNF-a, IFN-y, IL-1B, IL-4, IL-6, IL-8, IL-10 levels in serum
Örebro University, Sweden
Other
Exploratory Study on the Effects of Probiotic Supplementation on SARS-CoV-2 Antibody Response in Healthy Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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