Seasonal Allergic Rhinitis
Conditions
Brief summary
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.
Detailed description
To identify immune markers in allergic individuals that are impacted by probiotic treatment during seasonal exposure
Interventions
DIETARY_SUPPLEMENTMaltodextrin
maltodextrin powder
DIETARY_SUPPLEMENTProbiotic
probiotic blended in maltodextrin powder
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed allergy (allergic rhinitis) to grass pollen \> 1 year and positive SPT \> 3mm wheal diameter to grass pollen. * Age 20-65 years adults * Body Mass Index 19- 29 (people in the normal and overweight range) * Having obtained his/her informed consent.
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 * Subject who cannot be expected to comply with the study procedures, including consuming the test products * Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 0 (baseline), 1 and 2 months | 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. |
| 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) | 0 (baseline), 1, and 2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) | Measures at baseline, 1, and 2 months | 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. |
| 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 | — |
Countries
Switzerland
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Placebo maltodextrin powder
Maltodextrin : maltodextrin powder | 10 |
| Probiotic probiotic blended in maltodextrin
Probiotic : probiotic blended in maltodextrin powder | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Probiotic | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 20 Participants | 10 Participants |
| Age Continuous | 35.5 years | 34.7 years | 34 years |
| Region of Enrollment Switzerland | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 0 (baseline), 1 and 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | IL13 at V1 (beginning of product intake) | 1238 ng/mL | Standard Error 1453 |
| Placebo | 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) | IL13 at 1 month (4 weeks) | 975 ng/mL | Standard Error 1019 |
| Placebo | 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) | IL13 at 2 months (8 weeks) | 968 ng/mL | Standard Error 1206 |
| Probiotic | 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) | IL13 at V1 (beginning of product intake) | 720 ng/mL | Standard Error 854 |
| Probiotic | 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) | IL13 at 1 month (4 weeks) | 998 ng/mL | Standard Error 1383 |
| Probiotic | 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) | IL13 at 2 months (8 weeks) | 218 ng/mL | Standard Error 151 |
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.
Time frame: 0 (baseline), 1, and 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | IL-5 at baseline (begining of product intake) | 1439 ng/mL | Standard Deviation 1501 |
| Placebo | 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) | IL-5 at 1 month (4 weeks) | 1191 ng/mL | Standard Deviation 1005 |
| Placebo | 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) | IL-5 at 2 months (8 weeks) | 1277 ng/mL | Standard Deviation 956 |
| Probiotic | 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) | IL-5 at baseline (begining of product intake) | 700 ng/mL | Standard Deviation 683 |
| Probiotic | 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) | IL-5 at 1 month (4 weeks) | 980 ng/mL | Standard Deviation 905 |
| Probiotic | 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) | IL-5 at 2 months (8 weeks) | 323 ng/mL | Standard Deviation 301 |
Secondary
Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells
Time frame: 8 weeks
Secondary
Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups
Time frame: 8 weeks
Secondary
Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells
Time frame: 8 weeks
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.
Time frame: Measures at baseline, 1, and 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) | TNSS score at baseline | 4.10 units on a scale | Standard Deviation 3.11 |
| Placebo | Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) | TNSS score at 1 month | 3.05 units on a scale | Standard Deviation 1.86 |
| Placebo | Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) | TNSS score at 2 months | 3.00 units on a scale | Standard Deviation 2.04 |
| Probiotic | Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) | TNSS score at baseline | 4.90 units on a scale | Standard Deviation 3.35 |
| Probiotic | Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) | TNSS score at 1 month | 3.92 units on a scale | Standard Deviation 1.89 |
| Probiotic | Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) | TNSS score at 2 months | 1.50 units on a scale | Standard Deviation 1.33 |