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Microbiome Therapy in Covid-19 Primary Care Support (MiCel)

Primary Purpose

SARS-CoV Infection, Corona Virus Infection

Status
Suspended
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Microbiome spray
Placebo spray
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV Infection focused on measuring lactobacilli, Probiotics, Throat spray

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Veronique Verhoeven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Verum Microbiome spray group

Placebo spray group

Household member group

Arm Description

Daily use of microbiome spray for two weeks

Daily use of placebo spray for two weeks

No use of spray

Outcomes

Primary Outcome Measures

Change in severity of COVID-19 infection symptoms after using microbiome spray
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

Change in duration of COVID-19 infection symptoms after using microbiome spray
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.
Change in absolute numbers of SARS-CoV-2 after using microbiome spray
Quantification via qPCR
Change in absolute numbers of specific bacterial pathogens after using microbiome spray
Quantification via qPCR
Change in microbiome of nose/throat region after using microbiome spray.
Prevalence of antibodies against SARS-CoV-2 in the index patients' household members
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
Prevalence of COVID-19 in the index patients' household members
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.

Full Information

First Posted
February 28, 2021
Last Updated
May 31, 2021
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT04793997
Brief Title
Microbiome Therapy in Covid-19 Primary Care Support
Acronym
MiCel
Official Title
Covid-19 Primary Care Support With Microbiome Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Suspended
Why Stopped
Based on feedback from our study participants on the taste, spray optimization is necessary
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection, Corona Virus Infection
Keywords
lactobacilli, Probiotics, Throat spray

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind, randomized, placebo controlled
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verum Microbiome spray group
Arm Type
Active Comparator
Arm Description
Daily use of microbiome spray for two weeks
Arm Title
Placebo spray group
Arm Type
Placebo Comparator
Arm Description
Daily use of placebo spray for two weeks
Arm Title
Household member group
Arm Type
No Intervention
Arm Description
No use of spray
Intervention Type
Biological
Intervention Name(s)
Microbiome spray
Intervention Description
Throat spray containing 3 beneficial lactobacilli strains
Intervention Type
Biological
Intervention Name(s)
Placebo spray
Intervention Description
Throat spray
Primary Outcome Measure Information:
Title
Change in severity of COVID-19 infection symptoms after using microbiome spray
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Change in duration of COVID-19 infection symptoms after using microbiome spray
Description
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.
Time Frame
3 weeks
Title
Change in absolute numbers of SARS-CoV-2 after using microbiome spray
Description
Quantification via qPCR
Time Frame
3 weeks
Title
Change in absolute numbers of specific bacterial pathogens after using microbiome spray
Description
Quantification via qPCR
Time Frame
3 weeks
Title
Change in microbiome of nose/throat region after using microbiome spray.
Time Frame
3 weeks
Title
Prevalence of antibodies against SARS-CoV-2 in the index patients' household members
Description
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
Time Frame
3 weeks
Title
Prevalence of COVID-19 in the index patients' household members
Description
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.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Veronique Verhoeven
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium

12. IPD Sharing Statement

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Microbiome Therapy in Covid-19 Primary Care Support

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