Allergic RhinitisNCT01233154
Effect of a L. Paracasei Strain on Grass Pollen Allergic Rhinitis Subjects
A study testing probiotic in people with Allergic Rhinitis, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Various studies in animal and humans have shown a potential beneficial effect of probiotics consumption on allergy. However few studies exist that document their efficacy for upper airways allergies such as allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2007to Jun 2008
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-40 years old
- history of allergic rhinitis during the latest grass pollen season confirmed by a positive skin prick test to grass pollen (wheal diameter > 3mm) and a positive response to a NPT with grass pollen (combined nasal reaction threshold <= 10000 standardized quality units/ml at the screening phase
Who cannot join
- any medical condition that could influence the study (pregnancy, viral or bacterial airway infection, active allergic rhinitis)
- uncontrolled asthma (peak expiratory flow <20% of volunteer's best personal value)
- treatment with antihistamine or antibiotic treatment less than two weeks before enrolment or during the trial
Trial locations and contacts
1 site in 1 country.
About this study
Various studies in animal and humans have shown a potential beneficial effect of probiotics consumption on allergy. However few studies exist that document their efficacy for upper airways allergies such as allergic rhinitis. The objective of this study is to investigate the effect of short-term oral administration of a L. paracasei or of a blend of 2 probiotics (L. acidophilus + B. lactis) on a nasal provocation test (NPT) with grass pollen, performed out of the pollen season. Adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind study, based on two 4-weeks cross-over periods of product consumption separated by a washout period of 6-8 weeks. Objective and subjective clinical parameters of NPT as well as systemic and nasal immunological markers are compared before and after each treatment.
- Conditions
- Allergic Rhinitis
- Being tested
- probiotic
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| L. paracasei | Experimental | L. paracasei Receives: Dietary Supplement: probiotic |
| L. acidophilus + B. lactis | Experimental | L. acidophilus + B. lactis Receives: Dietary Supplement: probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal reaction threshold when provocation test with allergens
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startOct 2007
- Primary completionMar 2008
- Study completionJun 2008
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 Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233154
- Sponsor's protocol ID
- 07.27.NRC
- Status last verified
- Mar 2014
- First submitted
- 2 Nov 2010
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Perrin Y, Nutten S, Audran R, Berger B, Bibiloni R, Wassenberg J, Barbier N, Aubert V, Moulin J, Singh A, Magliola C, Mercenier A, Spertini F. Comparison of two oral probiotic preparations in a randomized crossover trial highlights a potentially beneficial effect of Lactobacillus paracasei NCC2461 in patients with allergic rhinitis. Clin Transl Allergy. 2014 Jan 6;4(1):1. doi: 10.1186/2045-7022-4-1.
PubMed 24393277
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a L. Paracasei Strain on Grass Pollen Allergic Rhinitis Subjects
- ClinicalTrials.gov ID
- NCT01233154
- Acronym / sponsor ID
- 07.27.NRC
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Nov 2010 (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.
Various studies in animal and humans have shown a potential beneficial effect of probiotics consumption on allergy. However few studies exist that document their efficacy for upper airways allergies such as allergic rhinitis. The objective of this study is to investigate the effect of short-term oral administration of a L. paracasei or of a blend of 2 probiotics (L. acidophilus + B. lactis) on a nasal provocation test (NPT) with grass pollen, performed out of the pollen season. Adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind study, based on two 4-weeks cross-over periods of product consumption separated by a washout period of 6-8 weeks. Objective and subjective clinical parameters of NPT as well as systemic and nasal immunological markers are compared before and after each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. paracasei | Experimental | Dietary Supplement: probioticL. paracasei |
| L. acidophilus + B. lactis | Experimental | Dietary Supplement: probioticL. acidophilus + B. lactis |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 18-40 years old
- history of allergic rhinitis during the latest grass pollen season confirmed by a positive skin prick test to grass pollen (wheal diameter > 3mm) and a positive response to a NPT with grass pollen (combined nasal reaction threshold <= 10000 standardized quality units/ml at the screening phase
Key exclusion criteria (3 listed)
- any medical condition that could influence the study (pregnancy, viral or bacterial airway infection, active allergic rhinitis)
- uncontrolled asthma (peak expiratory flow <20% of volunteer's best personal value)
- treatment with antihistamine or antibiotic treatment less than two weeks before enrolment or during the trial
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 |
|---|---|---|
| probiotic | Dietary supplement | L. paracasei |
| probiotic | Dietary supplement | L. acidophilus + B. lactis |
Primary outcome
Nasal reaction threshold when provocation test with allergens
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
- Results publication: PubMed 24393277Perrin Y, Nutten S, Audran R, Berger B, Bibiloni R, Wassenberg J, Barbier N, Aubert V, Moulin J, Singh A, Magliola C, Mercenier A, Spertini F. Comparison of two oral probiotic preparations in a randomized crossover trial highlights a potentially beneficial effect of Lactobacillus paracasei NCC2461 in patients with allergic rhinitis. Clin Transl Allergy. 2014 Jan 6;4(1):1. doi: 10.1186/2045-7022-4-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic in people with Allergic Rhinitis, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nasal reaction threshold when provocation test with allergens (time frame: 4 weeks). 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 NCT01233154, 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 5 Mar 2014.