NCT04734886

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2021

Completed
Last Updated

October 15, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

December 10, 2020

Last Update Submit

October 14, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • SARS-CoV-2 specific antibodies

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

    3 months (interim analysis) or at 6 months

Secondary Outcomes (15)

  • Maintenance of SARS-CoV-2 seroconversion in seropositive individuals

    3 months + 6 months

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

    3 months + 6 months

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

    3 months + 6 months

  • Secretory IgA (sIgA) antibodies

    3 months + 6 months

  • Blood group A antigen antibodies

    3 months + 6 months

  • +10 more secondary outcomes

Other Outcomes (3)

  • Composition of intestinal microbiota and COVID-19 related symptoms

    3 months + 6 months

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

    3 months + 6 months

  • Composition of intestinal microbiota and inflammatory profile

    3 months + 6 months

Study Arms (2)

L. reuteri DSM 17938

ACTIVE COMPARATOR

Probiotic compound

Dietary Supplement: L. reuteri DSM 17938 + vitamin D

Placebo

PLACEBO COMPARATOR

Placebo compound

Dietary Supplement: Placebo + vitamin D

Interventions

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

L. reuteri DSM 17938
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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed informed consent
  • Age between 18-60

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örebro University

Örebro, Örebro County, 703 62, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 24638909BACKGROUND

  • 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.

    PMID: 28923425BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Robert J Brummer, MD, PhD

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2020

First Posted

February 2, 2021

Study Start

November 27, 2020

Primary Completion

September 13, 2021

Study Completion

September 13, 2021

Last Updated

October 15, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

IPD will not be shared, results will shared only on group-level

Locations

SE(1)