Clinical trial NCT01660698: Immune-modulatory Effect of Probiotic Strain on Grass Pollen Allergic Individuals
Official title: Immune-modulatory Effect of Candidate Probiotic Strain on Whole Blood Cells of Grass Pollen Allergic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 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)
timeFrame: 0 (baseline), 1 and 2 months
measure: 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)
timeFrame: 0 (baseline), 1, and 2 months
Secondary outcomes:
measure: Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)
timeFrame: Measures at baseline, 1, and 2 months
measure: Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells
timeFrame: 8 weeks
measure: Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups
timeFrame: 8 weeks
measure: Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Metabolic Unit, Nestlé Research Center
state: VD
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Dr Maurice Beaumont, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.