Allergic RhinitisNCT01150253
Effect of a Probiotic on Grass Pollen Allergic Rhinitis Subjects
A study testing L. paracasei fermented milk in people with Allergic Rhinitis, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Various studies in animals 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 35 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- L. paracasei fermented milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2006to Mar 2007
- 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 35 years
- All sexes
- Adult
Who may be able to join
- age 18 to 35 years
- history of allergic rhinitis to grass pollen confirmed by either a positive skin prick test (wheal diameter >3 mm) or specific IgE for grass pollen (>0.35 kU/L) as titrated by UniCAP 100 (Pharmacia Diagnostics, Uppsala, Sweden) and no history of perennial rhinitis
- a nasal reaction threshold of 10'000 standardized quality units (SQs)/ml grass pollen or less 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
Official title: Double Blind Randomised Comparison of Two Preparations, One Enriched in Probiotics and One Without Probiotics (Placebo) in Grass Pollen Allergic Rhinitis Patients, Using a Nasal Provocation Test
Various studies in animals 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 Lactobacillus paracasei on a nasal provocation test (NPT) with grass pollen, performed out of pollen season. Adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind, placebo-controlled study, based on two 4-weeks cross-over periods of product consumption (probiotic-fermented milk versus placebo), separated by a washout period of 6-8 weeks. Objective and subjective clinical parameters of NPT as well as systemic and nasal immunological parameters are compared between the two treatment periods.
- Conditions
- Allergic Rhinitis
- Being tested
- L. paracasei fermented milk
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. paracasei fermented milkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| probiotic fermented milk | Experimental | Not described Receives: Dietary Supplement: L. paracasei fermented milk |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: L. paracasei fermented milk |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startAug 2006
- Primary completionMar 2007
- Study completionMar 2007
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
- Intervention model
- Crossover
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- François Spertini, Prof, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150253
- Sponsor's protocol ID
- 06.09.NRC
- Status last verified
- Jan 2014
- First submitted
- 23 Jun 2010
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wassenberg J, Nutten S, Audran R, Barbier N, Aubert V, Moulin J, Mercenier A, Spertini F. Effect of Lactobacillus paracasei ST11 on a nasal provocation test with grass pollen in allergic rhinitis. Clin Exp Allergy. 2011 Apr;41(4):565-73. doi: 10.1111/j.1365-2222.2011.03695.x.
PubMed 21395878
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomised Comparison of Two Preparations, One Enriched in Probiotics and One Without Probiotics (Placebo) in Grass Pollen Allergic Rhinitis Patients, Using a Nasal Provocation Test
- ClinicalTrials.gov ID
- NCT01150253
- Acronym / sponsor ID
- 06.09.NRC
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 24 Jun 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 animals 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 Lactobacillus paracasei on a nasal provocation test (NPT) with grass pollen, performed out of pollen season. Adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind, placebo-controlled study, based on two 4-weeks cross-over periods of product consumption (probiotic-fermented milk versus placebo), separated by a washout period of 6-8 weeks. Objective and subjective clinical parameters of NPT as well as systemic and nasal immunological parameters are compared between the two treatment periods.
Study design
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic fermented milk | Experimental | Dietary Supplement: L. paracasei fermented milk |
| placebo | Placebo comparator | Dietary Supplement: L. paracasei fermented milk |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18 to 35 years
- history of allergic rhinitis to grass pollen confirmed by either a positive skin prick test (wheal diameter >3 mm) or specific IgE for grass pollen (>0.35 kU/L) as titrated by UniCAP 100 (Pharmacia Diagnostics, Uppsala, Sweden) and no history of perennial rhinitis
- a nasal reaction threshold of 10'000 standardized quality units (SQs)/ml grass pollen or less 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 |
|---|---|---|
| L. paracasei fermented milk | Dietary supplement | placebo, probiotic fermented milk |
Primary outcome
Not reported in the source record.
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 14 Jan 2014.
- Results publication: PubMed 21395878Wassenberg J, Nutten S, Audran R, Barbier N, Aubert V, Moulin J, Mercenier A, Spertini F. Effect of Lactobacillus paracasei ST11 on a nasal provocation test with grass pollen in allergic rhinitis. Clin Exp Allergy. 2011 Apr;41(4):565-73. doi: 10.1111/j.1365-2222.2011.03695.x.
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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.
François Spertini, Prof principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. paracasei fermented milk 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 3 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 14 Jan 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. Some participants in this study may receive a placebo. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01150253, 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 14 Jan 2014.