Seasonal Allergic Rhinitis Study

NCT01123252 | Completed Phase 2

• 1 other identifier: UEA SAR 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Seasonal Affective Rhinitis; Asthma; Grass Allergy

Keywords

Lactobacillus casei

Outcome Measures

Primary Outcomes (1)

• Total nasal symptom score

  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.

  10 minutes following nasal allergen challenge

Secondary Outcomes (4)

• Area under the curve for nasal symptoms scores for 12 hours following nasal allergen challenge

  12 hours

• • Area under the curve for peak nasal inspiratory flow for 12 hours following nasal allergen challenge

  12 hours

• Phenotype of nasal epithelial cells from scrapings

  4 months

• Nasal lavage inflammatory mediator profile

  4 months

Study Arms (2)

Seasonal Affective Rhinitis Group 1

ACTIVE COMPARATOR

Active Comparator Group

Dietary Supplement: Lactobacillus casei Shirota (LcS)

Seasonal Affective Rhinitis Group 2

PLACEBO COMPARATOR

Placebo Group

Dietary Supplement: Placebo

Interventions

Lactobacillus casei Shirota (LcS) DIETARY_SUPPLEMENT

Subjects will receive one bottle of Yakult containing the probiotic bacterium Lactobacillus casei Shirota (active drink) once daily for 4 months (16 weeks).

Also known as: Yakult fermented milk

Seasonal Affective Rhinitis Group 1

Placebo DIETARY_SUPPLEMENT

Subjects will receive one bottle of a placebo milk drink, once daily for 4 months (16 weeks).

Seasonal Affective Rhinitis Group 2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of East Anglia: lead
• Quadram Institute Bioscience: collaborator
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator
• Yakult Honsha Co., LTD: collaborator

Study Sites (4)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

CRTU University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

Location

University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

Location

Related Publications (1)

• Ivory K, Wilson AM, Sankaran P, Westwood M, McCarville J, Brockwell C, Clark A, Dainty JR, Zuidmeer-Jongejan L, Nicoletti C. Oral delivery of a probiotic induced changes at the nasal mucosa of seasonal allergic rhinitis subjects after local allergen challenge: a randomised clinical trial. PLoS One. 2013 Nov 15;8(11):e78650. doi: 10.1371/journal.pone.0078650. eCollection 2013.

  PMID: 24260122 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Andrew Wilson

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 14, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

GB (4)