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

July 11, 2013 updated by: Nestlé

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • VD
      • Lausanne, VD, Switzerland, 1000
        • Metabolic Unit, Nestlé Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 (baseline), 1 and 2 months
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.
0 (baseline), 1, and 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measures at baseline, 1, and 2 months
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
8 weeks
Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups
Time Frame: 8 weeks
8 weeks
Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Dr Maurice Beaumont, MD, PhD, Nestle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

August 2, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 9, 2012

Study Record Updates

Last Update Posted (Estimate)

July 12, 2013

Last Update Submitted That Met QC Criteria

July 11, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.03.MET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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