search
Back to results

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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Maltodextrin
Probiotic
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Metabolic Unit, Nestlé Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Probiotic

Arm Description

maltodextrin powder

probiotic blended in maltodextrin

Outcomes

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)
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)
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)
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
Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups
Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells

Full Information

First Posted
August 2, 2012
Last Updated
July 11, 2013
Sponsor
Société des Produits Nestlé (SPN)
search

1. Study Identification

Unique Protocol Identification Number
NCT01660698
Brief Title
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

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
maltodextrin powder
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
probiotic blended in maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
maltodextrin powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
probiotic blended in maltodextrin powder
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
0 (baseline), 1 and 2 months
Title
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)
Description
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.
Time Frame
0 (baseline), 1, and 2 months
Secondary Outcome Measure Information:
Title
Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)
Description
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.
Time Frame
Measures at baseline, 1, and 2 months
Title
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
Title
Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups
Time Frame
8 weeks
Title
Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Maurice Beaumont, MD, PhD
Organizational Affiliation
Société des Produits Nestlé (SPN)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Metabolic Unit, Nestlé Research Center
City
Lausanne
State/Province
VD
ZIP/Postal Code
1000
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23299716
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs