Healthy VolunteersNCT03587545
Study of Probiotic Potential of Lactobacillus Strains in the Upper Respiratory Tract After Nasal Spray Application
A study testing Probiotic nasal spray in people with Healthy Volunteers and Chronic Rhinosinusitis (Diagnosis), run by University Hospital, Antwerp at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Chronic Rhinosinusitis (Diagnosis), Probiotics
- What is being tested?
- Probiotic nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2018to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CRS patient group: CRS diagnosed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Probiotic Potential of Nasopharyngeal Lactobacillus Strains in the Upper Respiratory Tract After Nasal Spray Application
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.
- Being tested
- Probiotic nasal spray, Placebo nasal spray
- Medical subject headings
- Disease, Nose Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic nasal sprayOther
Total daily nasal administration of 2*10^8 CFU of probiotic bacteria delivered via 2 servings.
Placebo nasal sprayOther
Two servings of nasal administration of placebo nasal spray (not containing probiotic bacteria)
| Study group | Role | What they receive |
|---|---|---|
| Healthy probiotic group LGG | Experimental | Daily intake by healthy volunteers of 2 dosages of LGG spray during 2 weeks. Probiotic nasal spray. Receives: Other: Probiotic nasal spray |
| Healthy probiotic group LAMBR2 | Experimental | Daily intake by healthy volunteers of 2 dosages of LAMBR2 spray during 2 weeks. Probiotic nasal spray. Receives: Other: Probiotic nasal spray |
| Healthy placebo group | Placebo comparator | Daily intake by healthy volunteers of 2 dosages of placebo spray during 2 weeks.
Placebo nasal spray. Receives: Other: Placebo nasal spray |
| CRS probiotic group LGG | Experimental | Daily intake by CRS patients of 2 dosages of LGG spray during 2 weeks. Probiotic nasal spray. Receives: Other: Probiotic nasal spray |
| CRS probiotic group LAMBR2 | Experimental | Daily intake by CRS patients of 2 dosages of LAMBR2 spray during 2 weeks. Probiotic nasal spray. Receives: Other: Probiotic nasal spray |
| CRS placebo group | Placebo comparator | Daily intake by CRS patients of 2 dosages of placebo spray during 2 weeks. Placebo nasal spray. Receives: Other: Placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (4)
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.
Measured: 3 years
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'.
Measured: 3 years
Therapeutic potential: nasal hyperreactivity
Nasal hyperreactivity symptoms will be evaluated before and after administration of the nasal spray.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start1 Jun 2018
- Primary completion10 Oct 2018
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethisch Comité, UZA, University Hospital, Antwerp
- Investigators
- Sarah Lebeer, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587545
- Sponsor's protocol ID
- B300201835709
- Status last verified
- Apr 2020
- First submitted
- 27 Jun 2018
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Probiotic Potential of Nasopharyngeal Lactobacillus Strains in the Upper Respiratory Tract After Nasal Spray Application
- ClinicalTrials.gov ID
- NCT03587545
- Acronym / sponsor ID
- B300201835709
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- Jul 2021 (estimated)
- First posted
- 16 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy probiotic group LGG | Experimental | Other: Probiotic nasal sprayDaily intake by healthy volunteers of 2 dosages of LGG spray during 2 weeks. Probiotic nasal spray. |
| Healthy probiotic group LAMBR2 | Experimental | Other: Probiotic nasal sprayDaily intake by healthy volunteers of 2 dosages of LAMBR2 spray during 2 weeks. Probiotic nasal spray. |
| Healthy placebo group | Placebo comparator | Other: Placebo nasal sprayDaily intake by healthy volunteers of 2 dosages of placebo spray during 2 weeks. Placebo nasal spray. |
| CRS probiotic group LGG | Experimental | Other: Probiotic nasal sprayDaily intake by CRS patients of 2 dosages of LGG spray during 2 weeks. Probiotic nasal spray. |
| CRS probiotic group LAMBR2 | Experimental | Other: Probiotic nasal sprayDaily intake by CRS patients of 2 dosages of LAMBR2 spray during 2 weeks. Probiotic nasal spray. |
| CRS placebo group | Placebo comparator | Other: Placebo nasal sprayDaily intake by CRS patients of 2 dosages of placebo spray during 2 weeks. Placebo nasal spray. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CRS patient group: CRS diagnosed
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic nasal sprayTotal daily nasal administration of 2*10^8 CFU of probiotic bacteria delivered via 2 servings. | Other | CRS probiotic group LAMBR2, CRS probiotic group LGG, Healthy probiotic group LAMBR2, Healthy probiotic group LGG |
| Placebo nasal sprayTwo servings of nasal administration of placebo nasal spray (not containing probiotic bacteria) | Other | CRS placebo group, Healthy placebo group |
Primary outcome
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.
4 secondary outcomes
Microbiome differences
Time frame: 3 years
Therapeutic potential: chronic rhinosinusitis
Time frame: 3 years
Therapeutic potential: nasal hyperreactivity
Time frame: 3 years
Therapeutic potential: SNOT-22 score
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Lebeer principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic nasal spray in people with Healthy Volunteers and Chronic Rhinosinusitis (Diagnosis), run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal persistence of lactobacilli (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.