MiCel: Microbiome Therapy in Covid-19 Primary Care Support

Sponsor
University Hospital, Antwerp (Other)
Overall Status
Suspended
CT.gov ID
NCT04793997
Collaborator
(none)
150
1
3
12
12.5

Study Details

Study Description

Brief Summary

This double-blind, randomized, placebo-controlled study aims to investigate whether a throat spray containing probiotic bacteria (i.e. microbiome spray) can reduce the symptoms and complaints of the SARS-CoV-2 virus in patients with mild to moderate symptoms. In addition, the aim is to investigate whether the microbiome spray can prevent transmission of the SARS-CoV-2 virus to household members.

Condition or Disease Intervention/Treatment Phase
  • Biological: Microbiome spray
  • Biological: Placebo spray
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blind, randomized, placebo controlledDouble blind, randomized, placebo controlled
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Covid-19 Primary Care Support With Microbiome Therapy.
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Verum Microbiome spray group

Daily use of microbiome spray for two weeks

Biological: Microbiome spray
Throat spray containing 3 beneficial lactobacilli strains

Placebo Comparator: Placebo spray group

Daily use of placebo spray for two weeks

Biological: Placebo spray
Throat spray

No Intervention: Household member group

No use of spray

Outcome Measures

Primary Outcome Measures

  1. Change in severity of COVID-19 infection symptoms after using microbiome spray [3 weeks]

    Change in severity of COVID-19 infection symptoms as assessed by a symptom score (min 0 - max 65) based on the presence and absence of fever and ten COVID-19 related symptoms and, if present, the four and five severity categories, respectively.

Secondary Outcome Measures

  1. Change in duration of COVID-19 infection symptoms after using microbiome spray [3 weeks]

    Change in duration of COVID-19 infection symptoms as assessed by a symptom score (min 0 - max 65) based on the presence and absence of fever and ten COVID-19 related symptoms and, if present, the four and five severity categories, respectively.

  2. Change in absolute numbers of SARS-CoV-2 after using microbiome spray [3 weeks]

    Quantification via qPCR

  3. Change in absolute numbers of specific bacterial pathogens after using microbiome spray [3 weeks]

    Quantification via qPCR

  4. Change in microbiome of nose/throat region after using microbiome spray. [3 weeks]

  5. Prevalence of antibodies against SARS-CoV-2 in the index patients' household members [3 weeks]

    The investigators will assess the prevalence of antibodies against SARS-CoV-2 in the index patients' household members based on the analysis of a capillary (fingerprick) blood sample stored on Whatman903 protein saver card

  6. Prevalence of COVID-19 in the index patients' household members [3 weeks]

    The investigators will assess the prevalence of COVID-19 in the index patients' household members based on the presence of symptoms reported in a symptom diary.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients in primary care with a positive SARS-CoV-2 test based on PCR

  • Instructed during screening and agreed not to use other probiotic nutritional supplements outside of the study during the study period

  • Sign the consent form

Exclusion Criteria:
  • Antibiotic use at baseline and during the study

  • Vaccinated against SARS-CoV-2 at start of the study (both for index patients and household members that participate)

  • Pregnant women

  • History of use of probiotic supplements in the past two weeks

  • Current diagnosis of cancer or immunosuppressive therapy within the past 6 months

  • Acute and chronic infectious and inflammatory upper airway diseases (eg acute / chronic rhinosinusitis)

  • Clinically significant bleeding disorder

  • Any other medical condition that, in the principal investigator's opinion, warrants exclusion from the trial

Contacts and Locations

Locations

Site City State Country Postal Code
1 Veronique Verhoeven Antwerp Belgium 2020

Sponsors and Collaborators

  • University Hospital, Antwerp

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sarah Lebeer, Prof. dr.ir., Universiteit Antwerpen
ClinicalTrials.gov Identifier:
NCT04793997
Other Study ID Numbers:
  • B3002021000018
First Posted:
Mar 11, 2021
Last Update Posted:
Jun 3, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sarah Lebeer, Prof. dr.ir., Universiteit Antwerpen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2021