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
  Purpose

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.


Condition Intervention
Seasonal Allergic Rhinitis
Dietary Supplement: Maltodextrin
Dietary Supplement: Probiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immune-modulatory Effect of Candidate Probiotic Strain on Whole Blood Cells of Grass Pollen Allergic Individuals

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: May 2011
Study Completion Date: January 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
maltodextrin powder
Dietary Supplement: Maltodextrin
maltodextrin powder
Active Comparator: Probiotic
probiotic blended in maltodextrin
Dietary Supplement: Probiotic
probiotic blended in maltodextrin powder

Detailed Description:

To identify immune markers in allergic individuals that are impacted by probiotic treatment during seasonal exposure

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01660698

Locations
Switzerland
Metabolic Unit, Nestlé Research Center
Lausanne, VD, Switzerland, 1000
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Dr Maurice Beaumont, MD, PhD Nestlé
  More Information

Publications:
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01660698     History of Changes
Other Study ID Numbers: 11.03.MET
Study First Received: August 2, 2012
Results First Received: April 2, 2013
Last Updated: July 11, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014