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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 2, 2012
CompletedFirst Posted
Study publicly available on registry
August 9, 2012
CompletedResults Posted
Study results publicly available
July 12, 2013
CompletedJuly 12, 2013
July 1, 2013
3 months
August 2, 2012
April 2, 2013
July 11, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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)
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 Outcomes (4)
Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)
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
8 weeks
Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups
8 weeks
Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells
8 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORmaltodextrin powder
Probiotic
ACTIVE COMPARATORprobiotic blended in maltodextrin
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Metabolic Unit, Nestlé Research Center
Lausanne, Canton of Vaud, 1000, Switzerland
Related Publications (1)
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.
PMID: 23299716RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Maurice Beaumont, Principal Investigator
- Organization
- Clinical Development Unit / Metabolic Unit
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Maurice Beaumont, MD, PhD
Société des Produits Nestlé (SPN)
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2012
First Posted
August 9, 2012
Study Start
May 1, 2011
Primary Completion
August 1, 2011
Study Completion
January 1, 2012
Last Updated
July 12, 2013
Results First Posted
July 12, 2013
Record last verified: 2013-07