Status:
COMPLETED
Effect of a Multistrain Probiotic on Allergic Rhinitis Symptoms and Gut Microbiota Composition in Atopic Patients
Lead Sponsor:
Università degli Studi di Ferrara
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The purpose of the current study is to evaluate the efficacy of administering a multistrain probiotic in adult human subjects suffering from allergic rhinitis and evaluate both symptomatology through ...
Detailed Description
Adult subjects (18-60) with documented allergic rhinitis will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 8 weeks. Total nasal symptom scor...
Eligibility Criteria
Inclusion
- Adults aged 18 to 65 years of age
- Established allergic rhinitis (clinical history of rhinorrhea, congestion, sneezing, pruritis \>2 years)
- Positive Skin Prick Test and/or Specific IgE to at least one aeroallergen.
- 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
- Subjects currently under treatment with antibiotics
- Subjects undergoing allergen immunotherapy
- Pregnancy
- Vasomotor rhinitis
- Nasal cavity disorders
- Ear infections
- Other chronic diseases (e.g. gastrointestinal, cardiovascular, infections)
- Subjects diagnosed with non-controlled 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
- Proton pump inhibitors 2-weeks prior to randomization
- Antibiotics 2-weeks prior to randomization
Key Trial Info
Start Date :
March 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05344352
Start Date
March 30 2022
End Date
June 30 2024
Last Update
December 6 2024
Active Locations (1)
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1
Azienda Ospedaliero Universitaria di Ferrara
Cona, Ferrara, Italy, 44124