Seasonal Allergic Rhinitis
Conditions
Keywords
grass pollen, allergic rhinitis, TNSS, miniRQLQ
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
DIETARY_SUPPLEMENTMaltodextrin
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total nasal symptom score (TNSS) | every day over 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| miniRQLQ | every week for 8 weeks | Validated rhinoconjunctivitis quality of life questionnaire (mini RQLQ) measured weekly |
| Individual nasal and ocular symptoms scores | every day over 8 weeks | — |
| Total ocular symptom score (TOSS) | every day over 8 weeks | — |
| Medication Score | every week over 8 weeks | — |
| Specific IgE | Baseline and end of study | — |
| Well being index | every week over 8 weeks | — |
Countries
Germany
Outcome results
None listed