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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03587545
• Other study ID #: B300201835709
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 2021

Study information

• Verified date: April 2020
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 2021
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Healthy Volunteers
• Nasal Disease
• Nose Diseases
• Probiotics
• Sprays

Intervention

Other:
• 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)

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Microbiome differences	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.	3 years
Secondary	Therapeutic potential: chronic rhinosinusitis	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 years
Secondary	Therapeutic potential: nasal hyperreactivity	Nasal hyperreactivity symptoms will be evaluated before and after administration of the nasal spray.	3 years
Secondary	Therapeutic potential: SNOT-22 score	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.	3 years

External Links

•   Related Info