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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

Immune-modulatory Effect of Candidate Probiotic Strain on Whole Blood Cells of Grass Pollen Allergic Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660698
• Other study ID #: 11.03.MET
• Status: Completed
• Phase: N/A
• First received: August 2, 2012
• Last updated: July 11, 2013
• Start date: May 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Dietary Supplement:
• Maltodextrin
maltodextrin powder
• Probiotic
probiotic blended in maltodextrin powder

Locations

Country	Name	City	State
Switzerland	Metabolic Unit, Nestlé Research Center	Lausanne	VD

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

References & 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 pol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	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	No
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)	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	No
Secondary	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.	Measures at baseline, 1, and 2 months	No
Secondary	Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells		8 weeks	No
Secondary	Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups		8 weeks	No
Secondary	Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells		8 weeks	No