Microbiome Therapy in Covid-19 Primary Care Support

NCT ID: NCT04793997

Last Updated: 2021-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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SARS-CoV Infection Corona Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind, randomized, placebo controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Verum Microbiome spray group

Daily use of microbiome spray for two weeks

Group Type ACTIVE_COMPARATOR

Microbiome spray

Intervention Type BIOLOGICAL

Throat spray containing 3 beneficial lactobacilli strains

Placebo spray group

Daily use of placebo spray for two weeks

Group Type PLACEBO_COMPARATOR

Placebo spray

Intervention Type BIOLOGICAL

Throat spray

Household member group

No use of spray

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Microbiome spray

Throat spray containing 3 beneficial lactobacilli strains

Intervention Type BIOLOGICAL

Placebo spray

Throat spray

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Sarah Lebeer

Prof. dr.ir.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Veronique Verhoeven

Antwerp, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B3002021000018

Identifier Type: -

Identifier Source: org_study_id

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