Effect of a Multistrain Probiotic on Allergic Rhinitis Symptoms and Gut Microbiota Composition in Atopic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Dietary Supplement: Multistrain Probiotic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mutistrain probiotic<br> | Dietary Supplement: Multistrain Probiotic<br>* 8-week daily administration<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 8-week daily administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 + after 4 weeks from the end of trial. | over 8 weeks + 4 week after the end of trial (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | over 8 weeks + 4 week after the end of trial (follow-up) | 
| Serological markers | ECP, Eosinophil count, total IgE | over 8 weeks + 4 week after the end of trial (follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota