Rhinitis, Allergic, Perennial
Conditions
Keywords
Dust mite, Perennial allergic rhinitis
Brief summary
The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the quality of life in adult subjects suffering from perennial allergic rhinit.
Interventions
DIETARY_SUPPLEMENTLactobacillus paracasei probiotic strain
DIETARY_SUPPLEMENTPlacebo
maltodextrin
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults between 20-65 years old * Confirmed allergy (allergic rhinitis) to dust mite for more than 2 years, as determined by anamnesis and by a miniRQLQ of ≥ 1 * Positive Skin prick testing measure greater than 3mm wheal diameter to the dermatophagoides pteronyssinus species of house dust mite extract * Body Mass Index 19-29 * Having obtained his/her informed consent
Exclusion criteria
* Anemia * Allergy to any food or medication * Asthma * Family history of congenital immunodeficiency or chronic consumption (more than one week at Screening) of immunosuppressive or anti-inflammatory treatments * Ongoing treatment with antibiotics or undergoing allergen immunotherapy at Screening * Consumption of probiotic and other dietary nutritional interventions * More than 2 drinks/day alcohol consumption or use of illicit drugs * Pregnant women * Subjects with expected low compliance * Blood donation in the past month or planning to donate blood until a month after the end of the study * Currently participating or having participated in another interventional clinical trial during the last four weeks prior to the beginning the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ) | 8 weeks | Compared over 8 weeks between the two treatment groups |
Secondary
| Measure | Time frame |
|---|---|
| Level of pro-inflammatory cytokines in ex-vivo stimulated whole blood cells | Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks |
| Basophil activation in ex-vivo stimulated whole blood cells | Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks |
| Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score | Measured weekly for the 8 weeks of product intake |
| Level of Specific Immunoglobulin E | Measured 2 times: at the start of product intake and after 8 weeks |
| Frequency of adverse events | during the 8 weeks of product intake |
Countries
Switzerland
Outcome results
None listed