Study of Probiotic Potential of Lactobacillus Strains in the Upper Respiratory Tract After Nasal Spray Application
NCT ID: NCT03587545
Last Updated: 2020-04-08
Study Results
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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2018-06-01
2021-07-31
Brief Summary
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In this study, the investigators want to deliver the Proof-of-Concept that the most promising isolated strain, Lactobacillus casei AMBR2 (LAMBR2) and the well-documented probiotic strain Lactobacillus rhamnosus GG (LGG) also have interesting properties in humans, i.e. that these strains are able to -temporarily- persist in the upper respiratory tract of healthy volunteers and CRS patients after daily nasal application via a nasal spray for 2 weeks. In addition, the investigators aim to explore whether the application of these strains has an impact on the nasopharyngeal microbiome via 16S rRNA amplicon sequencing and dedicated qPCR analysis.
Therefore, bacterial DNA from nasal swabs will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Furthermore, the concentration of the Lactobacillus and specific pathogens will be monitored via qPCR.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Healthy probiotic group LGG
Daily intake by healthy volunteers of 2 dosages of LGG spray during 2 weeks. Probiotic nasal spray.
Probiotic nasal spray
Total daily nasal administration of 2\*10\^8 CFU of probiotic bacteria delivered via 2 servings.
Healthy probiotic group LAMBR2
Daily intake by healthy volunteers of 2 dosages of LAMBR2 spray during 2 weeks. Probiotic nasal spray.
Probiotic nasal spray
Total daily nasal administration of 2\*10\^8 CFU of probiotic bacteria delivered via 2 servings.
Healthy placebo group
Daily intake by healthy volunteers of 2 dosages of placebo spray during 2 weeks.
Placebo nasal spray.
Placebo nasal spray
Two servings of nasal administration of placebo nasal spray (not containing probiotic bacteria)
CRS probiotic group LGG
Daily intake by CRS patients of 2 dosages of LGG spray during 2 weeks. Probiotic nasal spray.
Probiotic nasal spray
Total daily nasal administration of 2\*10\^8 CFU of probiotic bacteria delivered via 2 servings.
CRS probiotic group LAMBR2
Daily intake by CRS patients of 2 dosages of LAMBR2 spray during 2 weeks. Probiotic nasal spray.
Probiotic nasal spray
Total daily nasal administration of 2\*10\^8 CFU of probiotic bacteria delivered via 2 servings.
CRS placebo group
Daily intake by CRS patients of 2 dosages of placebo spray during 2 weeks. Placebo nasal spray.
Placebo nasal spray
Two servings of nasal administration of placebo nasal spray (not containing probiotic bacteria)
Interventions
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Probiotic nasal spray
Total daily nasal administration of 2\*10\^8 CFU of probiotic bacteria delivered via 2 servings.
Placebo nasal spray
Two servings of nasal administration of placebo nasal spray (not containing probiotic bacteria)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* no pregnant women
* no breastfeeding women
* no acute or chronic airway infections (except for CRS patients in CRS patient group)
* no cancer
* no autoimmune diseases
18 Years
ALL
Yes
Sponsors
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University Hospital, Antwerp
OTHER
Responsible Party
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Ethisch Comité, UZA
Principal Investigator
Principal Investigators
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Sarah Lebeer
Role: PRINCIPAL_INVESTIGATOR
Universiteit Antwerpen
Locations
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Antwerp University Hospital
Edegem, Antwerp, Belgium
Countries
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Related Links
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Related Info
Other Identifiers
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B300201835709
Identifier Type: -
Identifier Source: org_study_id
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