The Effect of Probiotic Supplementation on SARS-CoV-2 Antibody Response After COVID-19
- Conditions
- Covid19
- Interventions
- Dietary Supplement: L. reuteri DSM 17938 + vitamin DDietary Supplement: Placebo + vitamin D
- Registration Number
- NCT04734886
- Lead Sponsor
- Örebro University, Sweden
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
- Signed informed consent
- Age between 18-60
- Previous diagnosis of COVID-19 (by positive PCR) or previous confirmation of seropositivity to SARS-CoV-2
- Body Mass Index over 35 or under 16
- Current diagnosis of cancer or ongoing cancer treatment in the last 12 months
- Diabetes mellitus
- Cardiovascular disorder in need of pharmaceutical treatment
- Chronic kidney disease
- Chronic lung disease with decreased lung capacity
- Chronic liver disease with liver cirrhosis
- Current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
- Chronic neurological/neurodegenerative disease (e.g. Parkinson's disease)
- Decreased function of the adrenal cortex (e.g. Addison's disease)
- Autoimmune disease (e.g. rheumatoid arthritis)
- Chronic pain syndromes (e.g. fibromyalgia)
- Pregnancy or breast-feeding
- Immunodeficiency due to disease or ongoing medical treatment
- Regular intake of anti-inflammatory and/or other immunosuppressive medication within the last 3 months
- Use of anti-depressants within the last 3 months
- Antimicrobial treatment within the last 12 weeks before baseline sampling
- 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
- Inability to maintain current diet and lifestyle during the study period
- Alcohol or drug abuse
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description L. reuteri DSM 17938 L. reuteri DSM 17938 + vitamin D Probiotic compound Placebo Placebo + vitamin D Placebo compound
- Primary Outcome Measures
Name Time Method SARS-CoV-2 specific antibodies 3 months (interim analysis) or at 6 months Change in SARS-CoV-2 specific IgG/IgM antibodies in serum between the study arms
- Secondary Outcome Measures
Name Time Method Duration of COVID-19 symptoms measured by a weekly symptom questionnaire 3 months + 6 months Change in duration of COVID-19 related symptoms between the study arms
Maintenance of SARS-CoV-2 seroconversion in seropositive individuals 3 months + 6 months Change in the maintenance of SARS-CoV-2 specific IgG/IgM antibody levels in serum between the study arms
Intestinal inflammation 3 months + 6 months Change in faecal calprotectin levels between the study arms
Indirect marker of intestinal permeability 3 months + 6 months Change in LBP levels in plasma between the study arms
Blood group A antigen antibodies 3 months + 6 months Change in anti-A levels in serum between the study arms
T cell activation 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
Severity of COVID-19 symptoms measured by Ordinal Scale for Clinical Improvement (scale 0-7, a lower score corresponds to a better outcome) 3 months + 6 months Change in severity of COVID-19 related symptoms between the study arms
Secretory IgA (sIgA) antibodies 3 months + 6 months Change in sIgA levels in saliva between the study arms
Tn antigen antibodies 3 months + 6 months Change in anti-Tn levels in serum between the study arms
Cytokines 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
Intestinal barrier function 3 months + 6 months Change in I-FABP levels in plasma between the study arms
Blood group B antigen antibodies 3 months + 6 months Change in anti-B levels in serum between the study arms
Innate immune system activation 3 months + 6 months Change in high-sensitive C-reactive protein (hs-CRP) levels in plasma between the study groups
Total antibodies 3 months + 6 months Change in total IgG and IgM levels in serum between the study groups
B cell activation 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
Trial Locations
- Locations (1)
Örebro University
🇸🇪Örebro, Örebro Län, Sweden