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Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms

NCT ID: NCT01653652

Last Updated: 2013-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-12-31

Brief Summary

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The purpose of the current study is to evaluate the efficacy of administering a probiotic in adult human subjects suffering from allergic rhinitis during seasonal grass pollen exposure.

Detailed Description

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Adult subjects with documented seasonal allergic rhinitis (SAR) to grass pollen will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 8 weeks during the grass pollen allergy season. Total nasal symptom score (TNSS) will be compared over 8 weeks between the two treatment groups.

Conditions

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Seasonal Allergic Rhinitis

Keywords

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grass pollen allergic rhinitis TNSS miniRQLQ

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 to be taken daily

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Probiotic

Probiotic blended in maltodextrin powder to be taken daily

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Probiotic

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 to 65 years of age at the time of enrolment.
* Established seasonal allergic rhinitis (clinical history of rhinorrhea, congestion, sneezing, pruritis \>2 years)
* Positive Skin Prick Test (SPT)to Grass Pollen (GP).
* Presence of specific IgE to Grass Pollen (GP)
* Have a Body Mass Index in the range 19-32 kg/m2
* Have signed the consent form
* Have been instructed during screening and agreed to not take any probiotic containing products outside the study for the study period

Exclusion Criteria

* Subjects currently under treatment with antibiotics or undergoing allergen immunotherapy at the time of enrolment
* Pregnancy
* Vasomotor rhinitis, nasal cavity disorders (nasal polyps), ear infections otitis media).
* Other chronic diseases (e.g. gastrointestinal, cardiovascular, infections)
* Subjects diagnosed with asthma
* Subjects currently participating in another interventional clinical trial or having participated in another clinical trial in the last 2 months
* Subjects on chronic use of systemic corticosteroids prior to randomization
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Charité Research Organisation GmbH

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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11.31. NRC

Identifier Type: -

Identifier Source: org_study_id