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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mutistrain probiotic | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multistrain Probiotic | Dietary Supplement | 8-week daily administration |
| |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria di Ferrara | Cona | Ferrara | 44124 | Italy |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Placebo |
| Other |
8-week daily administration |
|
| 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) |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |