Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of the current study is to evaluate the efficacy of administering a probiotic in adult human subjects suffering from allergic rhinitis during seasonal grass pollen exposure.

Detailed Description
-----------------
Adult subjects with documented seasonal allergic rhinitis (SAR) to grass pollen will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 8 weeks during the grass pollen allergy season. Total nasal symptom score (TNSS) will be compared over 8 weeks between the two treatment groups.

Official Title
-----------------
Mitigation of Seasonal Allergic Rhinitis Symptoms in Adults by Probiotic Intervention

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic
* Dietary Supplement: Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 to 65 years of age at the time of enrolment. Established seasonal allergic rhinitis (clinical history of rhinorrhea, congestion, sneezing, pruritis >2 years) Positive Skin Prick Test (SPT)to Grass Pollen (GP). Presence of specific IgE to Grass Pollen (GP) Have a Body Mass Index in the range 19-32 kg/m2 Have signed the consent form Have been instructed during screening and agreed to not take any probiotic containing products outside the study for the study period Exclusion Criteria: Subjects currently under treatment with antibiotics or undergoing allergen immunotherapy at the time of enrolment Pregnancy Vasomotor rhinitis, nasal cavity disorders (nasal polyps), ear infections otitis media). Other chronic diseases (e.g. gastrointestinal, cardiovascular, infections) Subjects diagnosed with asthma Subjects currently participating in another interventional clinical trial or having participated in another clinical trial in the last 2 months Subjects on chronic use of systemic corticosteroids prior to randomization

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>maltodextrin powder to be taken daily | Dietary Supplement: Maltodextrin<br> <br> |
| Active Comparator: Probiotic<br>Probiotic blended in maltodextrin powder to be taken daily | Dietary Supplement: Probiotic<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total nasal symptom score (TNSS) | Total nasal symptom score (TNSS) measuring nasal congestion, runny nose, nasal itching and sneezing on a scale of 0-12 will be compared over 8 weeks between the two treatment groups. | every day over 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total ocular symptom score (TOSS) |  | every day over 8 weeks | 
| miniRQLQ | Validated rhinoconjunctivitis quality of life questionnaire (mini RQLQ) measured weekly | every week for 8 weeks | 
| Individual nasal and ocular symptoms scores |  | every day over 8 weeks | 
| Well being index |  | every week over 8 weeks | 
| Medication Score |  | every week over 8 weeks | 
| Specific IgE |  | Baseline and end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
grass pollen, allergic rhinitis, TNSS, miniRQLQ