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AzTrials

Covid19NCT04734886

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

A study testing L. reuteri DSM 17938 + vitamin D in people with Covid19, run by Örebro University, Sweden at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
L. reuteri DSM 17938 + vitamin D
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
161 participants
Where
1 siteSweden
Study dates
27 Nov 2020to 13 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Signed informed consent
  • Age between 18-60

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Örebro University

    Örebro, Örebro County, 703 62

Other trials in Sweden

About this study

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

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.

Read the 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.

Conditions
Covid19
Being tested
L. reuteri DSM 17938 + vitamin D, Placebo + vitamin D
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L. reuteri DSM 17938 + vitamin DDietary supplement

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

  • Placebo + vitamin DDietary 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

Study groups in NCT04734886
Study groupRoleWhat they receive
L. reuteri DSM 17938Active comparatorProbiotic compound
Receives: Dietary Supplement: L. reuteri DSM 17938 + vitamin D
PlaceboPlacebo comparatorPlacebo compound
Receives: Dietary Supplement: Placebo + vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SARS-CoV-2 specific antibodies

    Change in SARS-CoV-2 specific IgG/IgM antibodies in serum between the study arms

    Measured: 3 months (interim analysis) or at 6 months

Secondary outcomes (15)

  1. Maintenance of SARS-CoV-2 seroconversion in seropositive individuals

    Change in the maintenance of SARS-CoV-2 specific IgG/IgM antibody levels in serum between the study arms

    Measured: 3 months + 6 months

  2. Duration of COVID-19 symptoms measured by a weekly symptom questionnaire

    Change in duration of COVID-19 related symptoms between the study arms

    Measured: 3 months + 6 months

  3. Severity of COVID-19 symptoms measured by Ordinal Scale for Clinical Improvement (scale 0-7, a lower score corresponds to a better outcome)

    Change in severity of COVID-19 related symptoms between the study arms

    Measured: 3 months + 6 months

  4. Secretory IgA (sIgA) antibodies

    Change in sIgA levels in saliva between the study arms

    Measured: 3 months + 6 months

  5. Blood group A antigen antibodies

    Change in anti-A levels in serum between the study arms

    Measured: 3 months + 6 months

  6. Blood group B antigen antibodies

    Change in anti-B levels in serum between the study arms

    Measured: 3 months + 6 months

  7. Tn antigen antibodies

    Change in anti-Tn levels in serum between the study arms

    Measured: 3 months + 6 months

  8. Innate immune system activation

    Change in high-sensitive C-reactive protein (hs-CRP) levels in plasma between the study groups

    Measured: 3 months + 6 months

  9. Cytokines

    Change in TNF-a, IFN-y, IL-1B, IL-4, IL-6, IL-8, IL-10 levels in serum between the study groups

    Measured: 3 months + 6 months

  10. Total antibodies

    Change in total IgG and IgM levels in serum between the study groups

    Measured: 3 months + 6 months

  11. T cell activation

    Change in the proportion of SARS-CoV-2 specific T cells of all T cells in blood between the study arms

    Measured: 3 months + 6 months

  12. B cell activation

    Change in the proportion of SARS-CoV-2 specific B cells of all B cells in blood between the study arms

    Measured: 3 months + 6 months

  13. Intestinal inflammation

    Change in faecal calprotectin levels between the study arms

    Measured: 3 months + 6 months

  14. Intestinal barrier function

    Change in I-FABP levels in plasma between the study arms

    Measured: 3 months + 6 months

  15. Indirect marker of intestinal permeability

    Change in LBP levels in plasma between the study arms

    Measured: 3 months + 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2021
  2. Study start27 Nov 2020
  3. Primary completion13 Sep 2021
  4. Study completion13 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04734886
Sponsor's protocol ID
Provid
Status last verified
Sep 2021
First submitted
10 Dec 2020
Last updated
15 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared, results will shared only on group-level

Publications

  • 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.

    PubMed 24638909

  • 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.

    PubMed 28923425

Questions about this trial

What is this clinical trial studying?

A study testing L. reuteri DSM 17938 + vitamin D in people with Covid19, run by Örebro University, Sweden at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SARS-CoV-2 specific antibodies (time frame: 3 months (interim analysis) or at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04734886, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.

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