Probiotic Administration and Perennial Allergic Rhinitis

NCT ID: NCT01779895

Last Updated: 2014-04-09

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-09-30

Brief Summary

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The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the quality of life in adult subjects suffering from perennial allergic rhinit.

Detailed Description

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Conditions

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Rhinitis, Allergic, Perennial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NCC2461

probiotic blended in maltodextrin powder to be taken daily

Group Type ACTIVE_COMPARATOR

Lactobacillus paracasei probiotic strain

Intervention Type DIETARY_SUPPLEMENT

Placebo

maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

maltodextrin

Interventions

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Lactobacillus paracasei probiotic strain

Intervention Type DIETARY_SUPPLEMENT

Placebo

maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Adults between 20-65 years old
* Confirmed allergy (allergic rhinitis) to dust mite for more than 2 years, as determined by anamnesis and by a miniRQLQ of ≥ 1
* Positive Skin prick testing measure greater than 3mm wheal diameter to the dermatophagoides pteronyssinus species of house dust mite extract
* Body Mass Index 19-29
* Having obtained his/her informed consent

Exclusion Criteria

* Anemia
* Allergy to any food or medication
* Asthma
* Family history of congenital immunodeficiency or chronic consumption (more than one week at Screening) of immunosuppressive or anti-inflammatory treatments
* Ongoing treatment with antibiotics or undergoing allergen immunotherapy at Screening
* Consumption of probiotic and other dietary nutritional interventions
* More than 2 drinks/day alcohol consumption or use of illicit drugs
* Pregnant women
* Subjects with expected low compliance
* Blood donation in the past month or planning to donate blood until a month after the end of the study
* Currently participating or having participated in another interventional clinical trial during the last four weeks prior to the beginning the study
Minimum Eligible Age

20 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

Principal Investigators

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Maurice Beaumont, MD

Role: PRINCIPAL_INVESTIGATOR

Nestlé Research Centre

Locations

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Metabolic Unit, Nestlé Research Centre

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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12.18.MET

Identifier Type: -

Identifier Source: org_study_id

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