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Study of Probiotic Potential of Lactobacillus Strains in the Upper Respiratory Tract After Nasal Spray Application

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ClinicalTrials.gov Identifier: NCT03587545
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité, UZA, University Hospital, Antwerp

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Chronic Rhinosinusitis (Diagnosis) Probiotics Sprays Nasal Disease Other: Probiotic nasal spray Other: Placebo nasal spray Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Study of Probiotic Potential of Nasopharyngeal Lactobacillus Strains in the Upper Respiratory Tract After Nasal Spray Application
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Healthy probiotic group LGG
Daily intake by healthy volunteers of 2 dosages of LGG spray during 2 weeks. Probiotic nasal spray.
Other: Probiotic nasal spray
Total daily nasal administration of 2*10^8 CFU of probiotic bacteria delivered via 2 servings.

Experimental: Healthy probiotic group LAMBR2
Daily intake by healthy volunteers of 2 dosages of LAMBR2 spray during 2 weeks. Probiotic nasal spray.
Other: Probiotic nasal spray
Total daily nasal administration of 2*10^8 CFU of probiotic bacteria delivered via 2 servings.

Placebo Comparator: Healthy placebo group

Daily intake by healthy volunteers of 2 dosages of placebo spray during 2 weeks.

Placebo nasal spray.

Other: Placebo nasal spray
Two servings of nasal administration of placebo nasal spray (not containing probiotic bacteria)

Experimental: CRS probiotic group LGG
Daily intake by CRS patients of 2 dosages of LGG spray during 2 weeks. Probiotic nasal spray.
Other: Probiotic nasal spray
Total daily nasal administration of 2*10^8 CFU of probiotic bacteria delivered via 2 servings.

Experimental: CRS probiotic group LAMBR2
Daily intake by CRS patients of 2 dosages of LAMBR2 spray during 2 weeks. Probiotic nasal spray.
Other: Probiotic nasal spray
Total daily nasal administration of 2*10^8 CFU of probiotic bacteria delivered via 2 servings.

Placebo Comparator: CRS placebo group
Daily intake by CRS patients of 2 dosages of placebo spray during 2 weeks. Placebo nasal spray.
Other: Placebo nasal spray
Two servings of nasal administration of placebo nasal spray (not containing probiotic bacteria)




Primary Outcome Measures :
  1. Nasal persistence of lactobacilli [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. Microbiome differences [ Time Frame: 3 years ]
    After Illumina MiSeq sequencing, bio-informatic tools will be used to cluster bacteria into amplicon sequence variants (ASVs). Based on these ASVs, the investigators will compare the composition of the bacteria in the sampled niches and compare this composition between patient with and without intake of probiotics. The investigators will specifically screen for ASVs that are over- or underrepresented in both populations. Furthermore, special attention will go to screen for the typical nasopharyngeal pathogens such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis... and also to beneficial microbes such as lactic acid bacteria.

  2. Therapeutic potential: chronic rhinosinusitis [ Time Frame: 3 years ]
    Chronic rhinosinusitis symptoms will be evaluated before and after administration of the nasal spray. Participants should rate the complaints linked to CRS from 'not present' to 'serious'.

  3. Therapeutic potential: nasal hyperreactivity [ Time Frame: 3 years ]
    Nasal hyperreactivity symptoms will be evaluated before and after administration of the nasal spray.

  4. Therapeutic potential: SNOT-22 score [ Time Frame: 3 years ]
    The investigators will investigate whether the nasal intake of probiotics has an effect on the quality of life of CRS patients. Patients should rate general nasopharyngeal complaints from 0 to 5 where 0 means that there is no complaint and 5 means that there are serious complaints.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • CRS patient group: CRS diagnosed

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587545


Contacts
Contact: Olivier M Vanderveken + 32 3 821 33 84 Olivier.Vanderveken@uza.be
Contact: Ilke De Boeck +32 3 265 3217 ilke.deboeck@uantwerpen.be

Locations
Belgium
Antwerp University Hospital Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Olivier M Vanderveken, MD, PhD    + 32 3 821 33 84    Olivier.Vanderveken@uza.be   
Contact: Ilke De Boeck, MSc    +32 3 265 3217    ilke.deboeck@uantwerpen.be   
Principal Investigator: Olivier M Vanderveken, MD, PhD         
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Principal Investigator: Sarah Lebeer Universiteit Antwerpen

Additional Information:
Responsible Party: Ethisch Comité, UZA, Principal Investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03587545     History of Changes
Other Study ID Numbers: B300201835709
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Nose Diseases
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes