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
Results First Received: April 2, 2013  
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
Condition: Seasonal Allergic Rhinitis
Interventions: Dietary Supplement: Maltodextrin
Dietary Supplement: Probiotic

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment at the Metabolic Unit, (study no. 11.03.MET, NCT01660698) during the Grass Pollen (GP) season. Twenty seven adults volunteered, of which twenty four who gave written informed consent were screened for clinical history of allergy to GP > 2 years and a confirmatory skin prick test (SPT) to GP. Twenty subjects were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects assigned to either: probiotic or placebo groups and taking assigned product for 8 weeks with three visits: V1(at baseline), V2 (4 weeks after treatment) and V3 (8 weeks after treatment).

Reporting Groups
  Description
Placebo

maltodextrin powder

Maltodextrin : maltodextrin powder

Probiotic

probiotic blended in maltodextrin

Probiotic : probiotic blended in maltodextrin powder


Participant Flow:   Overall Study
    Placebo     Probiotic  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

maltodextrin powder

Maltodextrin : maltodextrin powder

Probiotic

probiotic blended in maltodextrin

Probiotic : probiotic blended in maltodextrin powder

Total Total of all reporting groups

Baseline Measures
    Placebo     Probiotic     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     0     0     0  
Age  
[units: years]
Mean ( Inter-Quartile Range )
  34  
  ( 29.25 to 44 )  
  35.5  
  ( 31.5 to 38 )  
  34.7  
  ( 29.25 to 44 )  
Gender  
[units: participants]
     
Female     6     6     12  
Male     4     4     8  
Region of Enrollment  
[units: participants]
     
Switzerland     10     10     20  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups   [ Time Frame: 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells   [ Time Frame: 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Maurice Beaumont, Principal Investigator
Organization: Clinical Development Unit / Metabolic Unit
phone: +41217858054
e-mail: maurice.beaumont@rdls.nestle.com


Publications of Results:

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