Probiotic Administration and Perennial Allergic Rhinitis

Study Overview
=================
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.

Official Title
-----------------
Effect of Probiotic Lactobacillus Paracasei NCC2461 on House Dust Mite Allergy

Conditions
-----------------
Rhinitis, Allergic, Perennial

Intervention / Treatment
-----------------
* Dietary Supplement: Lactobacillus paracasei probiotic strain
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NCC2461<br>probiotic blended in maltodextrin powder to be taken daily | Dietary Supplement: Lactobacillus paracasei probiotic strain<br> <br> |
| Placebo Comparator: Placebo<br>maltodextrin | Dietary Supplement: Placebo<br>* maltodextrin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ) | Compared over 8 weeks between the two treatment groups | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dust mite, Perennial allergic rhinitis