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Completed

NCT Number: NCT04734886

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro University

Örebro, Örebro County, 703 62, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Age between 18-60

Exclusion criteria

  • 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

Treatment and study plan

L. reuteri DSM 17938 + vitamin D

Dietary Supplement

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

Placebo + vitamin D

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

Primary outcomes

  1. SARS-CoV-2 specific antibodies

    Time frame: 3 months (interim analysis) or at 6 months

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

Secondary outcomes

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

    Time frame: 3 months + 6 months

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

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

    Time frame: 3 months + 6 months

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

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

    Time frame: 3 months + 6 months

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

  4. Secretory IgA (sIgA) antibodies

    Time frame: 3 months + 6 months

    Change in sIgA levels in saliva between the study arms

  5. Blood group A antigen antibodies

    Time frame: 3 months + 6 months

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

  6. Blood group B antigen antibodies

    Time frame: 3 months + 6 months

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

  7. Tn antigen antibodies

    Time frame: 3 months + 6 months

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

  8. Innate immune system activation

    Time frame: 3 months + 6 months

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

  9. Cytokines

    Time frame: 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

  10. Total antibodies

    Time frame: 3 months + 6 months

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

  11. T cell activation

    Time frame: 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

  12. B cell activation

    Time frame: 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

  13. Intestinal inflammation

    Time frame: 3 months + 6 months

    Change in faecal calprotectin levels between the study arms

  14. Intestinal barrier function

    Time frame: 3 months + 6 months

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

  15. Indirect marker of intestinal permeability

    Time frame: 3 months + 6 months

    Change in LBP levels in plasma between the study arms

Other outcomes

  1. Composition of intestinal microbiota and COVID-19 related symptoms

    Time frame: 3 months + 6 months

    Correlation of intestinal microbiota composition to duration and severity of COVID-19 related symptoms

  2. Composition of intestinal microbiota and SARS-CoV-2 specific antibody

    Time frame: 3 months + 6 months

    Correlation of intestinal microbiota composition to SARS-CoV-2 specific antibody levels in serum

  3. Composition of intestinal microbiota and inflammatory profile

    Time frame: 3 months + 6 months

    Correlation of intestinal microbiota composition to TNF-a, IFN-y, IL-1B, IL-4, IL-6, IL-8, IL-10 levels in serum

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • BioGaia AB

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 2, 2021
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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