Allergic Rhinitis
Conditions
Keywords
Microbiota
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.
Interventions
DIETARY_SUPPLEMENTMultistrain Probiotic
8-week daily administration
OTHERPlacebo
8-week daily administration
Sponsors
Università degli Studi di Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 * Proton pump inhibitors 2-weeks prior to randomization * Antibiotics 2-weeks prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total nasal symptom score (TNSS) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| Gut Microbiota changes on fecal samples | over 8 weeks + 4 week after the end of trial (follow-up) | Shotgun metagenomic sequencing and computational profiling with the tools in bioBAkery3. MetaPhlAn3.0 and HUMAnN3.0 will be used for taxonomic and functional profiling. Only the species showing a non-zero abundance in ≥5% of the samples will be considered in the cross-sectional and longitudinal analysis. P-values will be corrected for multiple hypothesis testing with Benjamini-Hochberg FDR procedure, and the longitudinal analysis was performed using a linear mixed-effects model. |
| Serological markers | over 8 weeks + 4 week after the end of trial (follow-up) | ECP, Eosinophil count, total IgE |
Countries
Italy
Outcome results
None listed