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The Effect of Probiotic Supplementation on SARS-CoV-2 Antibody Response After COVID-19

NCT ID: NCT04734886

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-27

Study Completion Date

2021-09-13

Brief Summary

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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

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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L. reuteri DSM 17938

Probiotic compound

Group Type ACTIVE_COMPARATOR

L. reuteri DSM 17938 + vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Placebo compound

Group Type PLACEBO_COMPARATOR

Placebo + vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioGaia AB

INDUSTRY

Sponsor Role collaborator

Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert J Brummer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

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Örebro University

Örebro, Örebro County, Sweden

Site Status

Countries

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Sweden

References

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Lehtoranta L, Pitkaranta A, Korpela R. Probiotics in respiratory virus infections. Eur J Clin Microbiol Infect Dis. 2014 Aug;33(8):1289-302. doi: 10.1007/s10096-014-2086-y. Epub 2014 Mar 18.

Reference Type BACKGROUND
PMID: 24638909 (View on PubMed)

Zimmermann P, Curtis N. The influence of probiotics on vaccine responses - A systematic review. Vaccine. 2018 Jan 4;36(2):207-213. doi: 10.1016/j.vaccine.2017.08.069. Epub 2017 Sep 18.

Reference Type BACKGROUND
PMID: 28923425 (View on PubMed)

Other Identifiers

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Provid

Identifier Type: -

Identifier Source: org_study_id