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Trial record 43 of 590 for:    maltodextrin

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

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.
 
ClinicalTrials.gov Identifier: NCT01660698
Recruitment Status : Completed
First Posted : August 9, 2012
Results First Posted : July 12, 2013
Last Update Posted : July 12, 2013
Sponsor:
Information provided by (Responsible Party):
Nestlé

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Seasonal Allergic Rhinitis
Interventions Dietary Supplement: Maltodextrin
Dietary Supplement: Probiotic
Enrollment 20
Recruitment Details 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 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).
Arm/Group Title Placebo Probiotic
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maltodextrin powder

Maltodextrin : maltodextrin powder

probiotic blended in maltodextrin

Probiotic : probiotic blended in maltodextrin powder

Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Placebo Probiotic Total
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maltodextrin powder

Maltodextrin : maltodextrin powder

probiotic blended in maltodextrin

Probiotic : probiotic blended in maltodextrin powder

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
34
(29.25 to 44)
35.5
(31.5 to 38)
34.7
(29.25 to 44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
6
  60.0%
6
  60.0%
12
  60.0%
Male
4
  40.0%
4
  40.0%
8
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Switzerland Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Probiotic
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maltodextrin powder

Maltodextrin : maltodextrin powder

probiotic blended in maltodextrin

Probiotic : probiotic blended in maltodextrin powder

Overall Number of Participants Analyzed 10 10
Mean (Standard Error)
Unit of Measure: ng/mL
IL13 at V1 (beginning of product intake) 1238  (1453) 720  (854)
IL13 at 1 month (4 weeks) 975  (1019) 998  (1383)
IL13 at 2 months (8 weeks) 968  (1206) 218  (151)
2.Primary Outcome
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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Probiotic
Hide Arm/Group Description:

maltodextrin powder

Maltodextrin : maltodextrin powder

probiotic blended in maltodextrin

Probiotic : probiotic blended in maltodextrin powder

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
IL-5 at baseline (begining of product intake) 1439  (1501) 700  (683)
IL-5 at 1 month (4 weeks) 1191  (1005) 980  (905)
IL-5 at 2 months (8 weeks) 1277  (956) 323  (301)
3.Secondary Outcome
Title Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Probiotic
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maltodextrin powder

Maltodextrin : maltodextrin powder

probiotic blended in maltodextrin

Probiotic : probiotic blended in maltodextrin powder

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
TNSS score at baseline 4.10  (3.11) 4.90  (3.35)
TNSS score at 1 month 3.05  (1.86) 3.92  (1.89)
TNSS score at 2 months 3.00  (2.04) 1.50  (1.33)
4.Secondary Outcome
Title Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells
Hide Description [Not Specified]
Time Frame 8 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups
Hide Description [Not Specified]
Time Frame 8 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells
Hide Description [Not Specified]
Time Frame 8 weeks
Outcome Measure Data Not Reported
Time Frame From baseline until 4 weeks following the last product intake
Adverse Event Reporting Description All adverse events were documented on the the e-CRFs. In the case of a SAE persisting beyond trial termination, a follow up visit may be required. Any potential cause-effect relationship between the study product and the adverse event was assessed based on all examinations and laboratory analysis.
 
Arm/Group Title Placebo Probiotic
Hide Arm/Group Description

maltodextrin powder

Maltodextrin : maltodextrin powder

probiotic blended in maltodextrin

Probiotic : probiotic blended in maltodextrin powder

All-Cause Mortality
Placebo Probiotic
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Probiotic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Probiotic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Maurice Beaumont, Principal Investigator
Organization: Clinical Development Unit / Metabolic Unit
Phone: +41217858054
EMail: maurice.beaumont@rdls.nestle.com
Layout table for additonal information
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