Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms

November 19, 2013 updated by: Nestlé

Mitigation of Seasonal Allergic Rhinitis Symptoms in Adults by Probiotic Intervention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charite Research Organisation GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
maltodextrin powder to be taken daily
Dietary supplement: Maltodextrin
Active Comparator: Probiotic
Probiotic blended in maltodextrin powder to be taken daily
Dietary supplement: Probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total nasal symptom score (TNSS)
Time Frame: every day over 8 weeks
Total nasal symptom score (TNSS) measuring nasal congestion, runny nose, nasal itching and sneezing on a scale of 0-12 will be compared over 8 weeks between the two treatment groups.
every day over 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total ocular symptom score (TOSS)
Time Frame: every day over 8 weeks
every day over 8 weeks
miniRQLQ
Time Frame: every week for 8 weeks
Validated rhinoconjunctivitis quality of life questionnaire (mini RQLQ) measured weekly
every week for 8 weeks
Individual nasal and ocular symptoms scores
Time Frame: every day over 8 weeks
every day over 8 weeks
Well being index
Time Frame: every week over 8 weeks
every week over 8 weeks
Medication Score
Time Frame: every week over 8 weeks
every week over 8 weeks
Specific IgE
Time Frame: Baseline and end of study
Baseline and end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 27, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (Estimate)

July 31, 2012

Study Record Updates

Last Update Posted (Estimate)

November 20, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.31. NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Seasonal Allergic Rhinitis

Clinical Trials on Probiotic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe