Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01653652
First received: July 27, 2012
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Seasonal Allergic Rhinitis
Dietary Supplement: Probiotic
Dietary Supplement: Maltodextrin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mitigation of Seasonal Allergic Rhinitis Symptoms in Adults by Probiotic Intervention

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Total nasal symptom score (TNSS) [ Time Frame: every day over 8 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: every day over 8 weeks ] [ Designated as safety issue: No ]
  • miniRQLQ [ Time Frame: every week for 8 weeks ] [ Designated as safety issue: No ]
    Validated rhinoconjunctivitis quality of life questionnaire (mini RQLQ) measured weekly

  • Individual nasal and ocular symptoms scores [ Time Frame: every day over 8 weeks ] [ Designated as safety issue: No ]
  • Well being index [ Time Frame: every week over 8 weeks ] [ Designated as safety issue: No ]
  • Medication Score [ Time Frame: every week over 8 weeks ] [ Designated as safety issue: No ]
  • Specific IgE [ Time Frame: Baseline and end of study ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653652

Locations
Germany
Charité Research Organisation GmbH
Berlin, Germany
Sponsors and Collaborators
Nestlé
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01653652     History of Changes
Other Study ID Numbers: 11.31. NRC
Study First Received: July 27, 2012
Last Updated: November 19, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Nestlé:
grass pollen
allergic rhinitis
TNSS
miniRQLQ

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 16, 2014