Study of Probiotic Potential of Lactobacillus Strains in the Upper Respiratory Tract After Nasal Spray Application
1 other identifier
interventional
120
1 country
1
Brief Summary
Probiotics are defined as "live micro-organisms that, when administered in adequate amounts, confer a health benefit to the host" (Hill et al, 2014). These microbes are generally applied in the gastrointestinal tract via fermented food products or capsules. In previous research, the investigators isolated bacterial strains with potential probiotic properties for the upper respiratory tract based on in vitro laboratory tests, in vivo mice experiments and genome sequencing. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy-volunteers
Started Jun 2018
Longer than P75 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 27, 2018
CompletedFirst Posted
Study publicly available on registry
July 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedApril 8, 2020
April 1, 2020
4 months
June 27, 2018
April 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Nasal persistence of lactobacilli
After DNA extraction of the biological samples, the relative and absolute concentration of the administered probiotics will be monitored via microbiome analysis and qPCR. This will give information about the capacity of the probiotics to colonize the nasopharynx.
3 years
Secondary Outcomes (4)
Microbiome differences
3 years
Therapeutic potential: chronic rhinosinusitis
3 years
Therapeutic potential: nasal hyperreactivity
3 years
Therapeutic potential: SNOT-22 score
3 years
Study Arms (6)
Healthy probiotic group LGG
EXPERIMENTALDaily intake by healthy volunteers of 2 dosages of LGG spray during 2 weeks. Probiotic nasal spray.
Healthy probiotic group LAMBR2
EXPERIMENTALDaily intake by healthy volunteers of 2 dosages of LAMBR2 spray during 2 weeks. Probiotic nasal spray.
Healthy placebo group
PLACEBO COMPARATORDaily intake by healthy volunteers of 2 dosages of placebo spray during 2 weeks. Placebo nasal spray.
CRS probiotic group LGG
EXPERIMENTALDaily intake by CRS patients of 2 dosages of LGG spray during 2 weeks. Probiotic nasal spray.
CRS probiotic group LAMBR2
EXPERIMENTALDaily intake by CRS patients of 2 dosages of LAMBR2 spray during 2 weeks. Probiotic nasal spray.
CRS placebo group
PLACEBO COMPARATORDaily intake by CRS patients of 2 dosages of placebo spray during 2 weeks. Placebo nasal spray.
Interventions
Total daily nasal administration of 2\*10\^8 CFU of probiotic bacteria delivered via 2 servings.
Two servings of nasal administration of placebo nasal spray (not containing probiotic bacteria)
Eligibility Criteria
You may qualify if:
- CRS patient group: CRS diagnosed
You may not qualify if:
- no patients with trisomy 21
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Antwerp University Hospital
Edegem, Antwerp, 2650, Belgium
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Lebeer
Universiteit Antwerpen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 27, 2018
First Posted
July 16, 2018
Study Start
June 1, 2018
Primary Completion
October 10, 2018
Study Completion
July 1, 2021
Last Updated
April 8, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share