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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

maltodextrin powder

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

maltodextrin powder

Probiotic

probiotic blended in maltodextrin

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

probiotic blended in maltodextrin powder

Interventions

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Maltodextrin

maltodextrin powder

Intervention Type DIETARY_SUPPLEMENT

Probiotic

probiotic blended in maltodextrin powder

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No