Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01653652
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : November 20, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Dietary Supplement: Probiotic Dietary Supplement: Maltodextrin Not Applicable

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  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mitigation of Seasonal Allergic Rhinitis Symptoms in Adults by Probiotic Intervention
Study Start Date : April 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Total ocular symptom score (TOSS) [ Time Frame: every day over 8 weeks ]
  2. miniRQLQ [ Time Frame: every week for 8 weeks ]
    Validated rhinoconjunctivitis quality of life questionnaire (mini RQLQ) measured weekly

  3. Individual nasal and ocular symptoms scores [ Time Frame: every day over 8 weeks ]
  4. Well being index [ Time Frame: every week over 8 weeks ]
  5. Medication Score [ Time Frame: every week over 8 weeks ]
  6. Specific IgE [ Time Frame: Baseline and end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01653652

Charité Research Organisation GmbH
Berlin, Germany
Sponsors and Collaborators

Responsible Party: Nestlé Identifier: NCT01653652     History of Changes
Other Study ID Numbers: 11.31. NRC
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: November 2013

Keywords provided by Nestlé:
grass pollen
allergic rhinitis

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