We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01660698
First Posted: August 9, 2012
Last Update Posted: July 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]
    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 ]
    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 ]
    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 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 2, 2012
First Posted: August 9, 2012
Results First Submitted: April 2, 2013
Results First Posted: July 12, 2013
Last Update Posted: July 12, 2013
Last Verified: July 2013

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