Study of the Probiotic Potential of a Lacticaseibacillus Strain in the Upper Airways in Patients With Allergic Rhinoconjunctivitis After Administration in a Chewable
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Transfer of L. rhamnosus GG (estimated CFU counts) to the oronasopharyngeal cavity after administration of the chewable
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Probiotic group
daily use of a probiotic chewable for 8 weeks
Intervention: Probiotic chewables (Biological)
Placebo group
daily use of the placebo chewable for 8 weeks
Intervention: Placebo chewables (Biological)
Outcomes
Primary Outcomes
Transfer of L. rhamnosus GG (estimated CFU counts) to the oronasopharyngeal cavity after administration of the chewable
Time Frame: at 8 weeks
qPCR
Changes in the score of allergic rhinitis symptoms
Time Frame: over the study period (= 10 weeks)
Daily questionnaires will be used, in which a self-reported Total Nasal Symptom Score (TNSS) based on rhinorrhea, nasal congestion, nasal itching and sneezing with symptom severity ranging from 0 (no problem) to 12 (very severe problem) will be recorded.
Secondary Outcomes
- changes in microbiome of the oronasopharyngeal region after administration of the chewable(baseline, 8 weeks)
- Inlfuence on general nose- and mouth health(baseline, 8 weeks, 10 weeks)
- Changes in the absolute numbers of specific airway pathogens and viruses(baseline, 8 weeks)
- 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(baseline, 8 weeks)
- Frequency of medication use(over the study period (= 10 weeks))
Investigators
Sarah Lebeer
Prof. dr.ir.
University Hospital, Antwerp