HayfeverPhase 3NCT00554736
Lactobacillus Acidophilus L92 on Markers of Allergic Inflammation by Nasal Provocation With Grass Pollen
A Phase 3 study testing Lactobacillus acidophilus L-92 in people with Hayfever, run by University of California, Davis.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hayfever
- What is being tested?
- Lactobacillus acidophilus L-92
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Aug 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Show all 26Show fewer
- 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
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial of Lactobacillus Acidophilus L92 on Markers of Allergic Inflammation by Nasal Provocation With Grass Pollen
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.
Read the detailed description
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. This will be done by noting:
- The threshold dose of pollen extract required on nasal challenge needed to elicit nasal obstruction as measured by acoustic rhinometry pre-treatment, and then comparing the nasal response to the same dose at the end of treatment.
- 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.
- Changes in the cytokine and chemokine profile obtained by analysis of the nasal secretion specimens pre- and post-treatment.
- Changes in the cytokine profile of cultured peripheral blood mononuclear cells stimulated with PHA pre- and post-treatment.
- PHADIA ImmunoCAP perennial ryegrass pollen titer pre- and post-treatment.
- The threshold concentration of standardized perennial ryegrass extract to elicit a positive skin prick test pre- and post-treatment
- Total serum IgE pre- and post-
The active product to be used is a tablet made from desiccated Lactobacillus acidophilus strain L-92 and fillers. These bacteria are present in the GI tract of most healthy humans. They are non-pathogenic, and have been used in the food industry for preparation of fermented foods for centuries. They lower the pH of their environment by converting sugar to lactic acid, which inhibits the growth of some pathogens. Lactobacilli are the first genus of bacteria suspected to have health benefits. Most Probiotic studies have been done with live cultures, and indeed there is animal model literature to support greater beneficial immunomodulatory effects of live bacteria over killed organisms. However, some beneficial effects of Lactobacilli are proposed to be due to uptake and processing of cell wall components and bacterial DNA, thus interaction with living bacteria may not be required for all the beneficial effects. However, if a tablet form can deliver live bacteria, in terms of ease of consumption by consumers, it would be preferred by many people, as well as allowing easier blinding of the supplement in clinical trials. The study proposed herein will be the first large study of this product using a live, but desiccated tablet preparation of the bacteria. If this product has a beneficial effect, the fact that it is in a tablet form will greatly benefit consistency in manufacturing, as well as ease storage and ultimate use of the product by consumers.
CALPIS has selected a strain of lactobacilli, L. acidophilus (L92), on the basis of an IgE- lowering effect in experimental studies with mice. This product, in a liquid fermented milk form, has been tested in the following clinical studies:
- Cedar pollen allergy study (2003). Significant improvement in symptom-medication score was detected (ISHIDA et al BIOSCI. BIOTECH. BIOCHEM. 1652-60, 2005). Product: Liquid fermentation L acidophilus L-92 milk, heat-treated at 75°C for 10 minutes in 100 mL volume.
- Perennial allergic rhinitis (2002/03). Significant improvement in symptom-medication score was observed (ISHIDA et al J. Dairy Sci. 528-33, 2005). Product: 100 mL heat-treated milk fermented by L acidophilus L-92 (about 3x1010 counts/100 mL)
- Atopic dermatitis (2005). Improvement in symptom-medication score was detected. Unpublished data. Product: 100 mL fermented milk with L acidophilus L-92. An initial study using a desiccated form in tablets has been performed:
- Artificial pollen allergy study (2005). Improvement in quality of life was noted. Product: desiccated bacteria and fillers in tablets. 20 mg, 60 mg and 180 mg were studied. 180 mg/day was most effective. Unpublished data.
METHODS
PHASE 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 placebo and active treatment for 4 months. Randomization will be based upon a retrospective Rhinitis Quality of Life Questionnaire regarding their recollection of the worst week of the last pollen season. The intent is to randomize subjects such that the distribution of those with severe versus mild allergy symptoms is equal in both groups. The subjects will be evaluated for their nasal function (patency by acoustic rhinometry) and undergo a nasal provocation test and collection of nasal secretions at the beginning and end of the study. Blood will be drawn and skin tests will be performed at the beginning and end of the study.
Primary Objective:
To assess the efficacy of L-92 versus placebo by comparing the change in nasal obstruction using acoustic rhinometry from the baseline, upon nasal provocation with the same dose of grass pollen extract found to elicit obstruction at enrollment.
Secondary objectives:
- To compare the change in threshold dose for nasal specific provocation (NPT) test with grass pollen required to elicit nasal obstruction.
- To compare the change of serum IgE levels to grass pollen (performed by PHADIA ImmunoCAP) and total IgE.
- To compare the change of cytokines IFN-gamma, IL-2, IL-4, IL-5, IL-9 and IL-13, and the chemokine, eotaxin, in nasal secretion fluid using the same dose of pollen that elicited nasal obstruction at baseline.
- To compare the change of cytokines IFN-gamma, IL-2, IL-4, IL-5, IL-9 and IL-13 in the supernatant from peripheral blood mononuclear cells (PBMCs) stimulated with PHA pre and post-treatment.
PHASE 2
In the second phase:
Subjects will be given the option to participate for Phase 2 of the study. In this phase, subjects will continue on either placebo or active product throughout the next pollen season, starting in January 2008, and fill out Rhinitis Quality of Life Questionnaires when they pick up the study tablets at the beginning of April, May and June. They will be asked to fill out daily medication/symptom diaries during the first two weeks of May (exact dates subject to change depending on climatic factors). The peak grass pollen season is April through June. Blood will be drawn at a last visit in late June 2008 for specific and total IgE by ImmunoCAP.
- Conditions
- Hayfever
- Being tested
- Lactobacillus acidophilus L-92
- Keywords
- Pollen Allergy, Allergy
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus acidophilus L-92Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Lactobacillus acidophilus L-92 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startMay 2006
- Primary completionDec 2007 (estimated)
- Study completionAug 2008 (estimated)
Why it stopped: Sponsor suspended study do to funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HayfeverStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fu-Tong Liu, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554736
- Sponsor's protocol ID
- 200614299-2
- Other IDs
- 200614299-1
- Status last verified
- Apr 2015
- First submitted
- 5 Nov 2007
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15653517
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial of Lactobacillus Acidophilus L92 on Markers of Allergic Inflammation by Nasal Provocation With Grass Pollen
- ClinicalTrials.gov ID
- NCT00554736
- Acronym / sponsor ID
- 200614299-2
- Conditions
- Hayfever
- Keywords
- Pollen Allergy, Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor suspended study do to funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Dec 2007 (estimated)
- Study completion
- Aug 2008 (estimated)
- First posted
- 7 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. This will be done by noting:
- The threshold dose of pollen extract required on nasal challenge needed to elicit nasal obstruction as measured by acoustic rhinometry pre-treatment, and then comparing the nasal response to the same dose at the end of treatment.
- 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.
- Changes in the cytokine and chemokine profile obtained by analysis of the nasal secretion specimens pre- and post-treatment.
- Changes in the cytokine profile of cultured peripheral blood mononuclear cells stimulated with PHA pre- and post-treatment.
- PHADIA ImmunoCAP perennial ryegrass pollen titer pre- and post-treatment.
- The threshold concentration of standardized perennial ryegrass extract to elicit a positive skin prick test pre- and post-treatment
- Total serum IgE pre- and post-
The active product to be used is a tablet made from desiccated Lactobacillus acidophilus strain L-92 and fillers. These bacteria are present in the GI tract of most healthy humans. They are non-pathogenic, and have been used in the food industry for preparation of fermented foods for centuries. They lower the pH of their environment by converting sugar to lactic acid, which inhibits the growth of some pathogens. Lactobacilli are the first genus of bacteria suspected to have health benefits. Most Probiotic studies have been done with live cultures, and indeed there is animal model literature to support greater beneficial immunomodulatory effects of live bacteria over killed organisms. However, some beneficial effects of Lactobacilli are proposed to be due to uptake and processing of cell wall components and bacterial DNA, thus interaction with living bacteria may not be required for all the beneficial effects. However, if a tablet form can deliver live bacteria, in terms of ease of consumption by consumers, it would be preferred by many people, as well as allowing easier blinding of the supplement in clinical trials. The study proposed herein will be the first large study of this product using a live, but desiccated tablet preparation of the bacteria. If this product has a beneficial effect, the fact that it is in a tablet form will greatly benefit consistency in manufacturing, as well as ease storage and ultimate use of the product by consumers.
CALPIS has selected a strain of lactobacilli, L. acidophilus (L92), on the basis of an IgE- lowering effect in experimental studies with mice. This product, in a liquid fermented milk form, has been tested in the following clinical studies:
- Cedar pollen allergy study (2003). Significant improvement in symptom-medication score was detected (ISHIDA et al BIOSCI. BIOTECH. BIOCHEM. 1652-60, 2005). Product: Liquid fermentation L acidophilus L-92 milk, heat-treated at 75°C for 10 minutes in 100 mL volume.
- Perennial allergic rhinitis (2002/03). Significant improvement in symptom-medication score was observed (ISHIDA et al J. Dairy Sci. 528-33, 2005). Product: 100 mL heat-treated milk fermented by L acidophilus L-92 (about 3x1010 counts/100 mL)
- Atopic dermatitis (2005). Improvement in symptom-medication score was detected. Unpublished data. Product: 100 mL fermented milk with L acidophilus L-92. An initial study using a desiccated form in tablets has been performed:
- Artificial pollen allergy study (2005). Improvement in quality of life was noted. Product: desiccated bacteria and fillers in tablets. 20 mg, 60 mg and 180 mg were studied. 180 mg/day was most effective. Unpublished data.
METHODS
PHASE 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 placebo and active treatment for 4 months. Randomization will be based upon a retrospective Rhinitis Quality of Life Questionnaire regarding their recollection of the worst week of the last pollen season. The intent is to randomize subjects such that the distribution of those with severe versus mild allergy symptoms is equal in both groups. The subjects will be evaluated for their nasal function (patency by acoustic rhinometry) and undergo a nasal provocation test and collection of nasal secretions at the beginning and end of the study. Blood will be drawn and skin tests will be performed at the beginning and end of the study.
Primary Objective:
To assess the efficacy of L-92 versus placebo by comparing the change in nasal obstruction using acoustic rhinometry from the baseline, upon nasal provocation with the same dose of grass pollen extract found to elicit obstruction at enrollment.
Secondary objectives:
- To compare the change in threshold dose for nasal specific provocation (NPT) test with grass pollen required to elicit nasal obstruction.
- To compare the change of serum IgE levels to grass pollen (performed by PHADIA ImmunoCAP) and total IgE.
- To compare the change of cytokines IFN-gamma, IL-2, IL-4, IL-5, IL-9 and IL-13, and the chemokine, eotaxin, in nasal secretion fluid using the same dose of pollen that elicited nasal obstruction at baseline.
- To compare the change of cytokines IFN-gamma, IL-2, IL-4, IL-5, IL-9 and IL-13 in the supernatant from peripheral blood mononuclear cells (PBMCs) stimulated with PHA pre and post-treatment.
PHASE 2
In the second phase:
Subjects will be given the option to participate for Phase 2 of the study. In this phase, subjects will continue on either placebo or active product throughout the next pollen season, starting in January 2008, and fill out Rhinitis Quality of Life Questionnaires when they pick up the study tablets at the beginning of April, May and June. They will be asked to fill out daily medication/symptom diaries during the first two weeks of May (exact dates subject to change depending on climatic factors). The peak grass pollen season is April through June. Blood will be drawn at a last visit in late June 2008 for specific and total IgE by ImmunoCAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Lactobacillus acidophilus L-92In 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
- 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
Key exclusion criteria (26 listed)
- History of nasal deviation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus acidophilus L-92Nasal 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. | Biological | 1 |
Primary outcome
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
1 secondary outcome
• 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Background: PubMed 15653517Ishida 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.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fu-Tong Liu, MD, PhD principal investigator
University of California, Davis
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactobacillus acidophilus L-92 in people with Hayfever, run by University of California, Davis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00554736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.