Seasonal Allergic Rhinitis Study (SAR)
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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] |
- 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
- = mild symptoms
- = moderate symptoms
- = 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.
- 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 |
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| 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 | |
| Principal Investigator: | Andrew Wilson | University of East Anglia |
More Information
No publications provided
| 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 May 23, 2013