N/A
N=20
Immune-modulatory Effect of Probiotic Strain on Grass Pollen Allergic Individuals
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01660698 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: 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) — 1238; 720; 975; 998 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Maltodextrin (Dietary_supplement); Probiotic (Dietary_supplement)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Société des Produits Nestlé (SPN)
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
1238; 720; 975; 998; 968; 218 | — |
| 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) |
1439; 700; 1191; 980; 1277; 323 | — |
| SECONDARY Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) |
4.10; 4.90; 3.05; 3.92; 3.00; 1.50 | — |
| SECONDARY Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells |
— | — |
| SECONDARY Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups |
— | — |
| SECONDARY Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01660698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.