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The purpose of the current study is to evaluate the effect of administering a probiotic strain on allergic symptoms and immune parameters (Th-2 cytokines, effector cells) in seasonal allergic rhinitis subjects.
To identify immune markers in allergic individuals that are impacted by probiotic treatment during seasonal exposure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | maltodextrin powder |
|
| Probiotic | Active Comparator | probiotic blended in maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maltodextrin | Dietary Supplement | maltodextrin powder |
| |
| Probiotic |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake) | A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines. | 0 (baseline), 1 and 2 months |
| Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake) | A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines. | 0 (baseline), 1, and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) | TNSS Questionnaire were distributed at every visit (1 questionnaire for every week). The scored questionnaire were collected at subsequent visits. The symptom scores for nasal congestion, runny nose, nasal itching and sneezing were expressed as weekly sums (scale 0-3 for each symptom). The TNSS was the weekly sum for all the symptoms (scale 0-12). The TNSS data were analyzed as both monthly averages (at V2 and V3 compared to baseline V1) and weekly TNSS scores. Monthly TNSS scores were calculated as average over the 4 weeks preceding the visits. The higher the score is, the worse the outcome is. |
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Inclusion Criteria:
Exclusion Criteria:
Anemia
Family history of congenital immunodeficiency
Regular consumption of immunosuppressive or anti-inflammatory treatment
Under medication against allergy (e.g. anti histaminic)
Avoid regular consumption of probiotic and other dietary nutritional interventions
Have a high alcohol consumption (more than 1 drink/day)
Consumption of illicit drugs
Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Dr Maurice Beaumont, MD, PhD | Société des Produits Nestlé (SPN) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic Unit, Nestlé Research Center | Lausanne | Canton of Vaud | 1000 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23299716 | Result | Singh A, Hacini-Rachinel F, Gosoniu ML, Bourdeau T, Holvoet S, Doucet-Ladeveze R, Beaumont M, Mercenier A, Nutten S. Immune-modulatory effect of probiotic Bifidobacterium lactis NCC2818 in individuals suffering from seasonal allergic rhinitis to grass pollen: an exploratory, randomized, placebo-controlled clinical trial. Eur J Clin Nutr. 2013 Feb;67(2):161-7. doi: 10.1038/ejcn.2012.197. Epub 2013 Jan 9. |
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Subjects assigned to either: probiotic or placebo groups and taking assigned product for 8 weeks with three visits: V1(at baseline), V2 (4 weeks after treatment) and V3 (8 weeks after treatment).
Recruitment at the Metabolic Unit, (study no. 11.03.MET, NCT01660698) during the Grass Pollen (GP) season. Twenty seven adults volunteered, of which twenty four who gave written informed consent were screened for clinical history of allergy to GP > 2 years and a confirmatory skin prick test (SPT) to GP. Twenty subjects were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | maltodextrin powder Maltodextrin : maltodextrin powder |
| FG001 | Probiotic | probiotic blended in maltodextrin Probiotic : probiotic blended in maltodextrin powder |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | maltodextrin powder Maltodextrin : maltodextrin powder |
| BG001 | Probiotic | probiotic blended in maltodextrin Probiotic : probiotic blended in maltodextrin powder |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake) | A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines. | Posted | Mean | Standard Error | ng/mL | 0 (baseline), 1 and 2 months |
|
From baseline until 4 weeks following the last product intake
All adverse events were documented on the the e-CRFs. In the case of a SAE persisting beyond trial termination, a follow up visit may be required. Any potential cause-effect relationship between the study product and the adverse event was assessed based on all examinations and laboratory analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | maltodextrin powder Maltodextrin : maltodextrin powder |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Maurice Beaumont, Principal Investigator | Clinical Development Unit / Metabolic Unit | +41217858054 | maurice.beaumont@rdls.nestle.com |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Dietary Supplement |
probiotic blended in maltodextrin powder |
|
| Measures at baseline, 1, and 2 months |
| Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells | 8 weeks |
| Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups | 8 weeks |
| Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells | 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) | TNSS Questionnaire were distributed at every visit (1 questionnaire for every week). The scored questionnaire were collected at subsequent visits. The symptom scores for nasal congestion, runny nose, nasal itching and sneezing were expressed as weekly sums (scale 0-3 for each symptom). The TNSS was the weekly sum for all the symptoms (scale 0-12). The TNSS data were analyzed as both monthly averages (at V2 and V3 compared to baseline V1) and weekly TNSS scores. Monthly TNSS scores were calculated as average over the 4 weeks preceding the visits. The higher the score is, the worse the outcome is. | Posted | Mean | Standard Deviation | units on a scale | Measures at baseline, 1, and 2 months |
|
|
|
| Secondary | Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells | Not Posted | 8 weeks |
| Secondary | Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups | Not Posted | 8 weeks |
| Secondary | Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells | Not Posted | 8 weeks |
| Primary | Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake) | A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines. | Posted | Mean | Standard Deviation | ng/mL | 0 (baseline), 1, and 2 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Probiotic | probiotic blended in maltodextrin Probiotic : probiotic blended in maltodextrin powder | 0 | 10 | 0 | 10 |
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| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D019602 |
| Food and Beverages |
| TNSS score at 2 months |
|
| IL-5 at 2 months (8 weeks) |
|