Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms

Nestlé

Status

Completed

Conditions

Seasonal Allergic Rhinitis

Treatments

Dietary Supplement: Probiotic

Dietary Supplement: Maltodextrin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01653652

11.31. NRC

Details and patient eligibility

About

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.

Full 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.

Enrollment

131 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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