An interventional study of Maltodextrin and Probiotic in Seasonal Allergic Rhinitis, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Switzerland. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-07-12.
Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Treatment
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
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 20 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pregnancy
maltodextrin powder
Dietary Supplement: Maltodextrin
probiotic blended in maltodextrin
Dietary Supplement: Probiotic
maltodextrin powder
probiotic blended in maltodextrin powder
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
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
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
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
Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups
Time frame: 8 weeks
Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells
Time frame: 8 weeks
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.
| Milestone | Placebo | Probiotic |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| ng/mL | Placebo | Probiotic |
|---|---|---|
| IL13 at V1 (beginning of product intake) | 1238 ± 1453 | 720 ± 854 |
| IL13 at 1 month (4 weeks) | 975 ± 1019 | 998 ± 1383 |
| IL13 at 2 months (8 weeks) | 968 ± 1206 | 218 ± 151 |
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.
| units on a scale | Placebo | Probiotic |
|---|---|---|
| TNSS score at baseline | 4.10 ± 3.11 | 4.90 ± 3.35 |
| TNSS score at 1 month | 3.05 ± 1.86 | 3.92 ± 1.89 |
| TNSS score at 2 months | 3.00 ± 2.04 | 1.50 ± 1.33 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
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.
| ng/mL | Placebo | Probiotic |
|---|---|---|
| IL-5 at baseline (begining of product intake) | 1439 ± 1501 | 700 ± 683 |
| IL-5 at 1 month (4 weeks) | 1191 ± 1005 | 980 ± 905 |
| IL-5 at 2 months (8 weeks) | 1277 ± 956 | 323 ± 301 |
Collected over From baseline until 4 weeks following the last product intake. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/10 (0%) | 0/10 (0%) |
| Probiotic | — | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Placebo | Probiotic | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Placebo | Probiotic | Total |
|---|---|---|---|
| Mean | 34 (29.25 to 44) | 35.5 (31.5 to 38) | 34.7 (29.25 to 44) |
| Sex: Female, Male(Participants) | Placebo | Probiotic | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 4 | 4 | 8 |
| Region of Enrollment(participants) | Placebo | Probiotic | Total |
|---|---|---|---|
| Switzerland | 10 | 10 | 20 |
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Société des Produits Nestlé (SPN)