Official Title
Exploratory Study on the Effects of Probiotic Supplementation on SARS-CoV-2 Antibody Response in Healthy Adults
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.

Completed
COVID19

Dietary Supplement: L. reuteri DSM 17938 + vitamin D

1 * 10^8 CFU of L. reuteri DSM 17938 + 10 ug vitamin D3, two capsules per day for 6 months

Dietary Supplement: Placebo + vitamin D

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 60 Years
Countries
Sweden
Locations

Örebro University
Örebro, Örebro Län, Sweden

Robert J Brummer, MD, PhD, Principal Investigator
Örebro University, Sweden

NCT Number
MeSH Terms
COVID-19
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins