Immune-modulatory Effect of Probiotic Strain on Grass Pollen Allergic Individuals

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01660698
First received: August 2, 2012
Last updated: July 11, 2013
Last verified: July 2013

August 2, 2012
July 11, 2013
May 2011
August 2011   (final data collection date for primary outcome 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) [ Time Frame: 0 (baseline), 1 and 2 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 0 (baseline), 1, and 2 months ] [ Designated as safety issue: No ]
    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.
Change from baseline in Th2 cytokines (IL-5, IL-13) at 8 weeks in ex vivo stimulated whole blood cells [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01660698 on ClinicalTrials.gov Archive Site
  • Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake) [ Time Frame: Measures at baseline, 1, and 2 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in TNSS (Total Nasal Symptom Score) scores at 8 weeks [ Time Frame: Weekly average of 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in immunoglobulin levels in serum between treatment groups [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in basophil activation at 8 weeks in ex vivo stimulated whole blood cells [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Immune-modulatory Effect of Probiotic Strain on Grass Pollen Allergic Individuals
Immune-modulatory Effect of Candidate Probiotic Strain on Whole Blood Cells of Grass Pollen Allergic Individuals

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
  • Dietary Supplement: Maltodextrin
    maltodextrin powder
  • Dietary Supplement: Probiotic
    probiotic blended in maltodextrin powder
  • Placebo Comparator: Placebo
    maltodextrin powder
    Intervention: Dietary Supplement: Maltodextrin
  • Active Comparator: Probiotic
    probiotic blended in maltodextrin
    Intervention: Dietary Supplement: Probiotic
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01660698
11.03.MET
Yes
Nestlé
Nestlé
Not Provided
Principal Investigator: Dr Maurice Beaumont, MD, PhD Nestlé
Nestlé
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP