Lactobacillus Acidophilus L92 on Markers of Allergic Inflammation by Nasal Provocation With Grass Pollen

This study has been withdrawn prior to enrollment.
(Sponsor suspended study do to funding)
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00554736
First received: November 5, 2007
Last updated: June 1, 2011
Last verified: June 2011
  Purpose

This is a placebo controlled double-blind single center study initiated and sponsored by CALPIS, Inc., Japan, and CALPIS U.S.A., Inc., Torrance, CA.

The overall objective of this study is to establish the benefit of a bacterial product, Lactobacillus acidophilus strain L-92 (CALPIS U.S.A., Inc., Torrance, CA), in patients with allergic rhinitis.


Condition Intervention Phase
Hayfever
Biological: Lactobacillus acidophilus L-92
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Trial of Lactobacillus Acidophilus L92 on Markers of Allergic Inflammation by Nasal Provocation With Grass Pollen

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • The objective is to establish the benefit of Lactobacillus acidophilus strain L-92 in patients with allergic rhinitis. The threshold dose of pollen extract required to elicit nasal obstruction as measured by acoustic rhinometry pre-treatment. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • The dose of pollen extract needed (by progressive dose escalation) to elicit nasal obstruction at the end of treatment if significant nasal obstruction is not reached with the pre-treatment dose. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2006
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
In the first phase, subjects with a history of grass pollinosis, with positive skin tests to grass, will be studied out of season and will be randomized to active treatment for 4 months.
Biological: Lactobacillus acidophilus L-92
Nasal challenge and acoustic rhinometry will be performed at the first study visit and again at the end of the 4-month supplement period. Standardized perennial ryegrass pollen extract (Lolium perenne) (Hollister-Stier, Inc., Spokane, WA) will be used. Dilutions of the standard product will be made in sterile saline prior to use. The standard product strength is 100,000 BAU/mL. Provocation will start with 100 BAU/mL, delivered as a 100 microliter puff into each nostril nose during breath holding, followed by expiration. Acoustic rhinometry, performed in each nostril, will be recorded at 15 minutes. A change of 30% from baseline in the composite score is considered significant. The dose will be increased every 20 minutes if there is no response. The concentrations used will be 100 BAU, 330 BAU, 1000 BAU, 3300 BAU, 10,000 BAU or 33,000 BAU/mL.

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  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Each subject qualified by entry criteria history in a brief phone interview will be invited to come to a screening visit. A brief history and targeted physical exam to detect inclusion and exclusion criteria, listed below, will be performed after obtaining informed consent. Then, if the subject still appears eligible, they will undergo allergy skin testing to perennial ryegrass pollen extract as a key inclusion criteria. Skin testing will utilize standard prick techniques with appropriate saline/glycerin controls. The cross sectional measurements of the wheal and flare reaction will be recorded. A positive test will require a wheal >3mm vs the control diluent.

Inclusion Criteria:

  • at least a 2-year clinical history of springtime allergic rhinitis
  • allergy to grass pollen, defined by positive case history and positive skin prick test
  • Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile
  • Females of childbearing potential should be using acceptable birth control methods
  • Patients who are normally active and otherwise judged to be in good health
  • Patients must be willing and able to give written informed consent and must provide this consent
  • Patients must be willing and able to attend required study visits
  • Patients must be able to follow instructions
  • Off allergy medication for at least one month prior to study entry (nasal corticosteroids, nasal azelastine, cromolyn sodium, IPRATROPRIUM bromide, antihistamines, leukotriene antagonists)

Exclusion Criteria:

  • History of nasal deviation

    • Current cigarette smoker
    • History of allergy symptoms August to January
    • History of nasal polyposis
    • History of asthma
    • Concurrent disease that might complicate or interfere with investigation or evaluation of the study medications
    • Concurrent use of any prohibited medication(s)
    • Chronic or intermittent use of inhaled, oral, intramuscular, intravenous, or potent or super-potent topical corticosteroids
    • Chronic use of long acting antihistamines and other concomitant medications that would affect assessment of the effectiveness of study drug(s)
    • Any systemic disorder that could interfere with the evaluation of the study medication(s)
    • Upper or lower respiratory infection requiring antibiotics within 14 days of the first visit
    • Diagnosis of sinusitis within 30 days of the first Baseline visit
    • Hypersensitivity to the study supplement tablet fillers
    • active or quiescent tuberculosis infection of the respiratory tract
    • nasal septal ulcers, nasal surgery or nasal trauma within 90 days of enrollment
    • Clinical history of anaphylaxis
    • Patients with contraindications for allergy vaccines
    • Clinical history of immunodeficiency, including immunosuppressant therapy
    • Patients with contraindications to adrenaline
    • Subject is taking β-blockers
    • Clinical history of drug or alcohol abuse that would interfere with the patient's participation in the study
    • Clinical history of severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could be expected to interfere with the study
    • Clinical history, or evidence, of nasolacrimal drainage system malfunction
    • Study site staff who would have access to the clinical study protocol
    • History of immunotherapy with grass pollen extract
    • Participation in any other investigational study within 30 days before entry into this study or concomitantly with this study
  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: NCT00554736

Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Fu-Tong Liu, MD, PhD University of California, Davis
  More Information

Publications:
Responsible Party: Fu-Tong Liu, MD, PhD, University of California Davis
ClinicalTrials.gov Identifier: NCT00554736     History of Changes
Other Study ID Numbers: 200614299-2, 200614299-1
Study First Received: November 5, 2007
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Pollen Allergy
Allergy

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014