Status:
COMPLETED
The Effect of Probiotic Supplementation on SARS-CoV-2 Antibody Response After COVID-19
Lead Sponsor:
Örebro University, Sweden
Collaborating Sponsors:
BioGaia AB
Conditions:
Covid19
Eligibility:
All Genders
18-60 years
Phase:
NA
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 rando...
Eligibility Criteria
Inclusion
- Signed informed consent
- Age between 18-60
Exclusion
- 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
Key Trial Info
Start Date :
November 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2021
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT04734886
Start Date
November 27 2020
End Date
September 13 2021
Last Update
October 15 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Örebro University
Örebro, Örebro County, Sweden, 703 62