Back to resultsEffect of a Probiotic on Seasonal Allergic Rhinitis Symptoms
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Probiotic
Maltodextrin
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring grass pollen, allergic rhinitis, TNSS, miniRQLQ
Eligibility Criteria
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
Sites / Locations
- Charité Research Organisation GmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Probiotic
Arm Description
maltodextrin powder to be taken daily
Probiotic blended in maltodextrin powder to be taken daily
Outcomes
Primary Outcome Measures
Total nasal symptom score (TNSS)
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.
Secondary Outcome Measures
Total ocular symptom score (TOSS)
miniRQLQ
Validated rhinoconjunctivitis quality of life questionnaire (mini RQLQ) measured weekly
Individual nasal and ocular symptoms scores
Well being index
Medication Score
Specific IgE
Full Information
NCT ID
NCT01653652
First Posted
July 27, 2012
Last Updated
November 19, 2013
Sponsor
Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT01653652
Brief Title
Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms
Official Title
Mitigation of Seasonal Allergic Rhinitis Symptoms in Adults by Probiotic Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
grass pollen, allergic rhinitis, TNSS, miniRQLQ
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
maltodextrin powder to be taken daily
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Probiotic blended in maltodextrin powder to be taken daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Primary Outcome Measure Information:
Title
Total nasal symptom score (TNSS)
Description
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.
Time Frame
every day over 8 weeks
Secondary Outcome Measure Information:
Title
Total ocular symptom score (TOSS)
Time Frame
every day over 8 weeks
Title
miniRQLQ
Description
Validated rhinoconjunctivitis quality of life questionnaire (mini RQLQ) measured weekly
Time Frame
every week for 8 weeks
Title
Individual nasal and ocular symptoms scores
Time Frame
every day over 8 weeks
Title
Well being index
Time Frame
every week over 8 weeks
Title
Medication Score
Time Frame
every week over 8 weeks
Title
Specific IgE
Time Frame
Baseline and end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Charité Research Organisation GmbH
City
Berlin
Country
Germany
12. IPD Sharing Statement
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Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms
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