Rhinitis, Allergic, PerennialNCT01779895
Probiotic Administration and Perennial Allergic Rhinitis
A study testing Lactobacillus paracasei probiotic strain in people with Rhinitis, Allergic, Perennial, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the quality of life in adult subjects suffering from perennial allergic rhinit. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Lactobacillus paracasei probiotic strain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2012to Sep 2013
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 20-65 years old
- Confirmed allergy (allergic rhinitis) to dust mite for more than 2 years, as determined by anamnesis and by a miniRQLQ of ≥ 1
- Positive Skin prick testing measure greater than 3mm wheal diameter to the dermatophagoides pteronyssinus species of house dust mite extract
- Body Mass Index 19-29
- Having obtained his/her informed consent
Who cannot join
- Anemia
- Allergy to any food or medication
- Asthma
- Family history of congenital immunodeficiency or chronic consumption (more than one week at Screening) of immunosuppressive or anti-inflammatory treatments
- Ongoing treatment with antibiotics or undergoing allergen immunotherapy at Screening
- Consumption of probiotic and other dietary nutritional interventions
Show all 11Show fewer
- More than 2 drinks/day alcohol consumption or use of illicit drugs
- Pregnant women
- Subjects with expected low compliance
- Blood donation in the past month or planning to donate blood until a month after the end of the study
- Currently participating or having participated in another interventional clinical trial during the last four weeks prior to the beginning the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotic Lactobacillus Paracasei NCC2461 on House Dust Mite Allergy
The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the quality of life in adult subjects suffering from perennial allergic rhinit.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Lactobacillus paracasei probiotic strain, Placebo
- Keywords
- Dust mite, Perennial allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus paracasei probiotic strainDietary supplement
PlaceboDietary supplement
maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| NCC2461 | Active comparator | probiotic blended in maltodextrin powder to be taken daily Receives: Dietary Supplement: Lactobacillus paracasei probiotic strain |
| Placebo | Placebo comparator | maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ)
Compared over 8 weeks between the two treatment groups
Measured: 8 weeks
Secondary outcomes (5)
Level of pro-inflammatory cytokines in ex-vivo stimulated whole blood cells
Measured: Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks
Basophil activation in ex-vivo stimulated whole blood cells
Measured: Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks
Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score
Measured: Measured weekly for the 8 weeks of product intake
Level of Specific Immunoglobulin E
Measured: Measured 2 times: at the start of product intake and after 8 weeks
Frequency of adverse events
Measured: during the 8 weeks of product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurice Beaumont, MD, Principal investigator, Nestlé Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779895
- Sponsor's protocol ID
- 12.18.MET
- Status last verified
- Apr 2014
- First submitted
- 22 Jan 2013
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Lactobacillus Paracasei NCC2461 on House Dust Mite Allergy
- ClinicalTrials.gov ID
- NCT01779895
- Acronym / sponsor ID
- 12.18.MET
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- Dust mite, Perennial allergic rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Jan 2013 (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.
The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the quality of life in adult subjects suffering from perennial allergic rhinit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCC2461 | Active comparator | Dietary Supplement: Lactobacillus paracasei probiotic strainprobiotic blended in maltodextrin powder to be taken daily |
| Placebo | Placebo comparator | Dietary Supplement: Placebomaltodextrin |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults between 20-65 years old
- Confirmed allergy (allergic rhinitis) to dust mite for more than 2 years, as determined by anamnesis and by a miniRQLQ of ≥ 1
- Positive Skin prick testing measure greater than 3mm wheal diameter to the dermatophagoides pteronyssinus species of house dust mite extract
- Body Mass Index 19-29
- Having obtained his/her informed consent
Key exclusion criteria (11 listed)
- Anemia
- Allergy to any food or medication
- Asthma
- Family history of congenital immunodeficiency or chronic consumption (more than one week at Screening) of immunosuppressive or anti-inflammatory treatments
- Ongoing treatment with antibiotics or undergoing allergen immunotherapy at Screening
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 paracasei probiotic strain | Dietary supplement | NCC2461 |
| Placebomaltodextrin | Dietary supplement | Placebo |
Primary outcome
Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ)
Time frame: 8 weeks
Compared over 8 weeks between the two treatment groups
5 secondary outcomes
Level of pro-inflammatory cytokines in ex-vivo stimulated whole blood cells
Time frame: Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks
Basophil activation in ex-vivo stimulated whole blood cells
Time frame: Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks
Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score
Time frame: Measured weekly for the 8 weeks of product intake
Level of Specific Immunoglobulin E
Time frame: Measured 2 times: at the start of product intake and after 8 weeks
Frequency of adverse events
Time frame: during the 8 weeks of product intake
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 9 Apr 2014.
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Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
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A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
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Dupilumab Effects Against Aeroallergen Challenge
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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.
Maurice Beaumont, MD principal investigator
Nestlé Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus paracasei probiotic strain in people with Rhinitis, Allergic, Perennial, 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 5 inclusion and 11 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 9 Apr 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.
What does the primary outcome measure?
Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2014.