Effect of a Multistrain Probiotic on Allergic Rhinitis Symptoms and Gut Microbiota Composition in Atopic Patients
- Conditions
- Allergic Rhinitis
- Interventions
- Dietary Supplement: Multistrain ProbioticOther: Placebo
- Registration Number
- NCT05344352
- Lead Sponsor
- Università degli Studi di Ferrara
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mutistrain probiotic Multistrain Probiotic - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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) ECP, Eosinophil count, total IgE
Trial Locations
- Locations (1)
Azienda Ospedaliero Universitaria di Ferrara
🇮🇹Cona, Ferrara, Italy