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

NCT00554736 | Withdrawn Phase 3 DMC

• 2 other identifiers: 200614299-2200614299-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hayfever

Keywords

Pollen Allergy; Allergy

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Secondary Outcomes (1)

• • 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.

  one year

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Lactobacillus acidophilus L-92 BIOLOGICAL

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.

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of California, Davis: lead

Related Publications (1)

• Ishida Y, Nakamura F, Kanzato H, Sawada D, Hirata H, Nishimura A, Kajimoto O, Fujiwara S. Clinical effects of Lactobacillus acidophilus strain L-92 on perennial allergic rhinitis: a double-blind, placebo-controlled study. J Dairy Sci. 2005 Feb;88(2):527-33. doi: 10.3168/jds.S0022-0302(05)72714-4.

  PMID: 15653517 BACKGROUND

Related Links

• University of California-Davis Department of Dermatology Clinical Research

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Fu-Tong Liu, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 7, 2007
• Study Start: May 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: August 1, 2008
• Last Updated: April 22, 2015

Record last verified: 2015-04