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

NCT00554736 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-04-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Fu-Tong Liu, MD, PhD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-12-31
Completion
2008-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00554736 on ClinicalTrials.gov