Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the quality of life in adult subjects suffering from perennial allergic rhinit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCC2461 | Active Comparator | probiotic blended in maltodextrin powder to be taken daily |
|
| Placebo | Placebo Comparator | maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus paracasei probiotic strain | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ) | Compared over 8 weeks between the two treatment groups | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Level of pro-inflammatory cytokines in ex-vivo stimulated whole blood cells | Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks | |
| Basophil activation in ex-vivo stimulated whole blood cells | Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maurice Beaumont, MD | Nestlé Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic Unit, Nestlé Research Centre | Lausanne | 1000 | Switzerland |
Not provided
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dietary Supplement |
maltodextrin |
|
| Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score | Measured weekly for the 8 weeks of product intake |
| Level of Specific Immunoglobulin E | Measured 2 times: at the start of product intake and after 8 weeks |
| Frequency of adverse events | during the 8 weeks of product intake |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |