MiCel: Microbiome Therapy in Covid-19 Primary Care Support
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 |
---|---|---|
|
N/A |
Study Design
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
- 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
- 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.
- Change in absolute numbers of SARS-CoV-2 after using microbiome spray [3 weeks]
Quantification via qPCR
- Change in absolute numbers of specific bacterial pathogens after using microbiome spray [3 weeks]
Quantification via qPCR
- Change in microbiome of nose/throat region after using microbiome spray. [3 weeks]
- 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
- 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
Inclusion Criteria:
-
Patients in primary care with a positive SARS-CoV-2 test based on PCR
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Instructed during screening and agreed not to use other probiotic nutritional supplements outside of the study during the study period
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Sign the consent form
Exclusion Criteria:
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Antibiotic use at baseline and during the study
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Vaccinated against SARS-CoV-2 at start of the study (both for index patients and household members that participate)
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Pregnant women
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History of use of probiotic supplements in the past two weeks
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Current diagnosis of cancer or immunosuppressive therapy within the past 6 months
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Acute and chronic infectious and inflammatory upper airway diseases (eg acute / chronic rhinosinusitis)
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Clinically significant bleeding disorder
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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.- B3002021000018