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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
131
Charité Research Organisation GmbH
Berlin, Germany
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.
Time frame: every day over 8 weeks
Total ocular symptom score (TOSS)
Time frame: every day over 8 weeks
miniRQLQ
Validated rhinoconjunctivitis quality of life questionnaire (mini RQLQ) measured weekly
Time frame: every week for 8 weeks
Individual nasal and ocular symptoms scores
Time frame: every day over 8 weeks
Well being index
Time frame: every week over 8 weeks
Medication Score
Time frame: every week over 8 weeks
Specific IgE
Time frame: Baseline and end of study
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