Seasonal Allergic Rhinitis Study (SAR)

This study has been completed.
Sponsor:
Collaborators:
Institute of Food Research
Norfolk and Norwich University Hospitals NHS Foundation Trust
Yakult Honsha Co., LTD
Information provided by:
University of East Anglia
ClinicalTrials.gov Identifier:
NCT01123252
First received: May 11, 2010
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

The study aims to examine the effect of probiotics on the clinical symptoms of allergic rhinitis and to elucidate some of the immunological mechanisms involved.


Condition Intervention Phase
Seasonal Affective Rhinitis
Asthma
Grass Allergy
Dietary Supplement: Lactobacillus casei Shirota (LcS)
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effect of Yoghurt-type Drink on Symptoms of Subjects Suffering Seasonal Allergic Rhinitis (SAR) [Rhinitis 2]

Resource links provided by NLM:


Further study details as provided by University of East Anglia:

Primary Outcome Measures:
  • Total nasal symptom score [ Time Frame: 10 minutes following nasal allergen challenge ] [ Designated as safety issue: No ]

    Following exposure to allergen, there is an immediate rise in the reported symptoms,the recording of the symptoms scored at various time points is referred to as the TNSS. Participants will be asked to record their symptoms on a 4 point scale, with 0 representing no symptoms and 3 representing maximal symptoms:

    0 = absent symptoms

    1. = mild symptoms
    2. = moderate symptoms
    3. = severe symptoms

    Symptoms will be recorded under the following: Sneezing / Itching / Rhinorrhoea / Congestion

    The individual symptoms will be summed to give a total nasal symptom score.



Secondary Outcome Measures:
  • Area under the curve for nasal symptoms scores for 12 hours following nasal allergen challenge [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • • Area under the curve for peak nasal inspiratory flow for 12 hours following nasal allergen challenge [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Phenotype of nasal epithelial cells from scrapings [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Nasal lavage inflammatory mediator profile [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Seasonal Affective Rhinitis Group 1
Active Comparator Group
Dietary Supplement: Lactobacillus casei Shirota (LcS)
Subjects will receive one bottle of Yakult containing the probiotic bacterium Lactobacillus casei Shirota (active drink) once daily for 4 months (16 weeks).
Other Name: Yakult fermented milk
Placebo Comparator: Seasonal Affective Rhinitis Group 2
Placebo Group
Dietary Supplement: Placebo
Subjects will receive one bottle of a placebo milk drink, once daily for 4 months (16 weeks).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women over 16 years of age.
  • A history of SAR for a minimum of 2 years before study entry.
  • Documentation of sensitivity by positive skin testing (by prick or intradermal methods) or by adequately validated in vitro tests for specific IgE (e.g., RAST, PRIST) to grass pollen within 12 months prior to enrolment. If this is not available, appropriate tests will be performed at screening.
  • Able to provide written informed consent

Exclusion Criteria:

  • Ingestion of probiotics as part of normal diet
  • Significant medical, surgical or psychiatric disease that in the opinion of the participants' attending physician would affect subject safety or influence the study outcome.
  • Symptoms of rhinitis at screening indicated by total symptom scores of more than 2 out of 12 (based on a combination of nasal symptoms of blockage, sneezing, rhinorrhoea and itching).
  • Current smokers or ex-smokers of <1 year or those who have smoked the equivalent of 20 cigarettes/day for 20 years or more.
  • Participants receiving any form of corticosteriod from 1 month prior to the study
  • Inadequate washout periods for the following:

Intranasal cromolyn (2 weeks) Intranasal or systemic decongestants (3 days) Intranasal or systemic antihistamines (3 days), except astemizole (6 weeks) or loratadine (10 days).

  • Documented evidence of acute or significant chronic sinusitis
  • A history of hypersensitivity to the milk or its products
  • Pregnant women or those planning a pregnancy. It is important not to include pregnant women in the study due to the possibility of miscarriage following anaphylaxis.
  • Lactating women are excluded as those infants breast fed by mothers responding to allergenic challenges can transmit the manifestations of allergic responses to the feeding infant via breast milk
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123252

Locations
United Kingdom
CRTU University of East Anglia
Norwich, Norfolk, United Kingdom, NR47TJ
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
University of East Anglia
Norwich, Norfolk, United Kingdom, NR47TJ
Sponsors and Collaborators
University of East Anglia
Institute of Food Research
Norfolk and Norwich University Hospitals NHS Foundation Trust
Yakult Honsha Co., LTD
Investigators
Principal Investigator: Andrew Wilson University of East Anglia
  More Information

No publications provided by University of East Anglia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Andrew Wilson, University of East Anglia
ClinicalTrials.gov Identifier: NCT01123252     History of Changes
Other Study ID Numbers: UEA SAR 1
Study First Received: May 11, 2010
Last Updated: August 22, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of East Anglia:
Lactobacillus casei

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

ClinicalTrials.gov processed this record on April 17, 2014