SARS-CoV InfectionMiCelNCT04793997
Microbiome Therapy in Covid-19 Primary Care Support
A study testing Microbiome spray in people with SARS-CoV Infection and Corona Virus Infection, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection, Corona Virus Infection
- What is being tested?
- Microbiome spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Covid-19 Primary Care Support With Microbiome Therapy.
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.
- Conditions
- SARS-CoV Infection, Corona Virus Infection
- Being tested
- Microbiome spray, Placebo spray
- Keywords
- lactobacilli, Probiotics, Throat spray
- Medical subject headings
- Severe Acute Respiratory Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome sprayBiological
Throat spray containing 3 beneficial lactobacilli strains
Placebo sprayBiological
Throat spray
| Study group | Role | What they receive |
|---|---|---|
| Verum Microbiome spray group | Active comparator | Daily use of microbiome spray for two weeks Receives: Biological: Microbiome spray |
| Placebo spray group | Placebo comparator | Daily use of placebo spray for two weeks Receives: Biological: Placebo spray |
| Household member group | No intervention | No use of spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (6)
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.
Measured: 3 weeks
Change in absolute numbers of SARS-CoV-2 after using microbiome spray
Quantification via qPCR
Measured: 3 weeks
Change in absolute numbers of specific bacterial pathogens after using microbiome spray
Quantification via qPCR
Measured: 3 weeks
Change in microbiome of nose/throat region after using microbiome spray.
Measured: 3 weeks
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
Measured: 3 weeks
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Why it stopped: Based on feedback from our study participants on the taste, spray optimization is necessary
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, randomized, placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Lebeer, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793997
- Sponsor's protocol ID
- B3002021000018
- Acronym
- MiCel
- Status last verified
- May 2021
- First submitted
- 28 Feb 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Primary Care Support With Microbiome Therapy.
- ClinicalTrials.gov ID
- NCT04793997
- Acronym / sponsor ID
- MiCel / B3002021000018
- Conditions
- SARS-CoV Infection, Corona Virus Infection
- Keywords
- lactobacilli, Probiotics, Throat spray
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Based on feedback from our study participants on the taste, spray optimization is necessary
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double blind, randomized, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Verum Microbiome spray group | Active comparator | Biological: Microbiome sprayDaily use of microbiome spray for two weeks |
| Placebo spray group | Placebo comparator | Biological: Placebo sprayDaily use of placebo spray for two weeks |
| Household member group | No intervention | –No use of spray |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiome sprayThroat spray containing 3 beneficial lactobacilli strains | Biological | Verum Microbiome spray group |
| Placebo sprayThroat spray | Biological | Placebo spray group |
Primary outcome
Change in severity of COVID-19 infection symptoms after using microbiome spray
Time frame: 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.
6 secondary outcomes
Change in duration of COVID-19 infection symptoms after using microbiome spray
Time frame: 3 weeks
Change in absolute numbers of SARS-CoV-2 after using microbiome spray
Time frame: 3 weeks
Change in absolute numbers of specific bacterial pathogens after using microbiome spray
Time frame: 3 weeks
Change in microbiome of nose/throat region after using microbiome spray.
Time frame: 3 weeks
Prevalence of antibodies against SARS-CoV-2 in the index patients' household members
Time frame: 3 weeks
Prevalence of COVID-19 in the index patients' household members
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbiome spray in people with SARS-CoV Infection and Corona Virus Infection, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of COVID-19 infection symptoms after using microbiome spray (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.