Studio Clinico Randomizzato in Doppio Cieco, Controllato Verso Placebo, a Gruppi Paralleli Sull'efficacia Clinica Di Un Prodotto a Base Di Probiotici Nel Migliorare I Sintomi Della Rinite Allergica Perenne E Stagionale
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Allergic Rhinitis
- Sponsor
- Università degli Studi di Ferrara
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Total nasal symptom score (TNSS)
- Status
- Completed
- Last Updated
- last year
Overview
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 validated questionnaires and gut microbiota modification during and after treatment.
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 score (TNSS), Rhinitis Control Assessment Test (RCAT), Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) will be compared over 12 weeks between the two treatment groups. In addition, serological markers (Eosinophil count, Total IgE and Eosinophilic cationic protein) and gut microbiota features will be evaluated over a 12 week period.
Investigators
Giacomo Caio
Professor, MD, PhD
Università degli Studi di Ferrara
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Total nasal symptom score (TNSS)
Time Frame: over 8 weeks + 4 week after the end of trial (follow-up)
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 + after 4 weeks from the end of trial.
Secondary Outcomes
- Gut Microbiota changes on fecal samples(over 8 weeks + 4 week after the end of trial (follow-up))
- Rhinitis Control Assessment Test (RCAT)(over 8 weeks + 4 week after the end of trial (follow-up))
- Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)(over 8 weeks + 4 week after the end of trial (follow-up))
- Serological markers(over 8 weeks + 4 week after the end of trial (follow-up))