Status:
COMPLETED
Probiotic Chewables in Allergic Rhinoconjunctivitis Patients
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
DSM Nutritional Products, Inc.
Conditions:
Allergic Rhinoconjunctivitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 sympto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04898686
Start Date
August 1 2020
End Date
August 6 2021
Last Update
April 15 2022
Active Locations (1)
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1
Antwerp University Hospital
Edegem, Belgium