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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 28, 2014