Clinical trial NCT04898686: Probiotic Chewables in Allergic Rhinoconjunctivitis Patients
Official title: Study of the Probiotic Potential of a Lacticaseibacillus Strain in the Upper Airways in Patients With Allergic Rhinoconjunctivitis After Administration in a Chewable
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinoconjunctivitis
Keywords: lactobacilli
microbiome
probiotic chewables
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2021-05-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind, randomized, placebo controlled
Primary purpose: TREATMENT

Brief summary: With this double- blind, randomised, placebo-controlled study, the investigators want to investigate the influence of a chewable with the probiotic strain Lacticaseibacillus rhamnosus GG on the symptoms and immunological markers of allergic rhinoconjunctivitis (AR). In addition, the investigators aim to study the influence of this probiotic chewable on the microbiome of the upper respiratory tract after administration in adults with AR. The bacterial and cytokine profiles in the naso- and oropharynx will be monitored before, during and after the treatment.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 at the time of registration;
* Seasonal allergic rhinoconjunctivitis (AR) in the context of grass pollen allergy diagnosed on the basis of anamnesis cfr. ARIA guidelines and positive skin prick test and / or immunocap assay;
* Positive skin prick test (SPT) for grass pollen and / or the presence of specific IgE for grass pollen, confirmed by a medical specialist, measured at the start of the study: Soluprick SQ Phleum pratense pollen 10 HEP - ALK and / or IgE specific immunocap assay Phleum pratense (timothy grass) (g6);
* Body Mass Index in the range of 19-32 kg / m2;
* Instructed during screening and agreed not to use other probiotic products outside of the study during the study period;
* Signed the consent form.

Exclusion Criteria:

* Antibiotic use at baseline and during the study;
* Pregnant women;
* Unstable / uncontrolled asthma (to be determined by investigator-physician);
* Sensitization to dust mites
* History of probiotic use in the past two weeks;
* Current diagnosis of cancer or immunosuppressive therapy within the past 6 months;
* Abnormalities of the oral mucosa;
* Acute and chronic infectious and inflammatory upper airway diseases (eg acute / chronic rhinosinusitis cfr. EPOS guidelines);
* Clinically significant bleeding disorder;
* Any other medical condition that, in the principal investigator's opinion, warrants exclusion from the trial;
* History of regular use (\> 3 days out of 7) of tobacco products within the previous two weeks

Primary outcomes:
measure: Transfer of L. rhamnosus GG (estimated CFU counts) to the oronasopharyngeal cavity after administration of the chewable
timeFrame: at 8 weeks
measure: Changes in the score of allergic rhinitis symptoms
timeFrame: over the study period (= 10 weeks)
Secondary outcomes:
measure: changes in microbiome of the oronasopharyngeal region after administration of the chewable
timeFrame: baseline, 8 weeks
measure: Inlfuence on general nose- and mouth health
timeFrame: baseline, 8 weeks, 10 weeks
measure: Changes in the absolute numbers of specific airway pathogens and viruses
timeFrame: baseline, 8 weeks
measure: Changes in cytokine levels (e.g. IL-10, IL-4, IL-5, IL-13) in oro- and nasopharynx samples, and cytokine and antibody levels in blood samples
timeFrame: baseline, 8 weeks
measure: Frequency of medication use
timeFrame: over the study period (= 10 weeks)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
Study officials:
affiliation: Universiteit Antwerpen
name: Sarah Lebeer, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Olivier Vanderveken, Prof
role: PRINCIPAL_INVESTIGATOR
References: