Seasonal Allergic RhinitisNCT01653652
Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms
A study testing Probiotic and Maltodextrin in people with Seasonal Allergic Rhinitis, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
Trial summary
The purpose of the current study is to evaluate the efficacy of administering a probiotic in adult human subjects suffering from allergic rhinitis during seasonal grass pollen exposure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Probiotic and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Dec 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years of age at the time of enrolment.
- Established seasonal allergic rhinitis (clinical history of rhinorrhea, congestion, sneezing, pruritis >2 years)
- Positive Skin Prick Test (SPT)to Grass Pollen (GP).
- Presence of specific IgE to Grass Pollen (GP)
- Have a Body Mass Index in the range 19-32 kg/m2
- Have signed the consent form
- Have been instructed during screening and agreed to not take any probiotic containing products outside the study for the study period
Who cannot join
- Subjects currently under treatment with antibiotics or undergoing allergen immunotherapy at the time of enrolment
- Pregnancy
- Vasomotor rhinitis, nasal cavity disorders (nasal polyps), ear infections otitis media).
- Other chronic diseases (e.g. gastrointestinal, cardiovascular, infections)
- Subjects diagnosed with asthma
- Subjects currently participating in another interventional clinical trial or having participated in another clinical trial in the last 2 months
- Subjects on chronic use of systemic corticosteroids prior to randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mitigation of Seasonal Allergic Rhinitis Symptoms in Adults by Probiotic Intervention
The purpose of the current study is to evaluate the efficacy of administering a probiotic in adult human subjects suffering from allergic rhinitis during seasonal grass pollen exposure.
Read the detailed description
Adult subjects with documented seasonal allergic rhinitis (SAR) to grass pollen will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 8 weeks during the grass pollen allergy season. Total nasal symptom score (TNSS) will be compared over 8 weeks between the two treatment groups.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Probiotic, Maltodextrin
- Keywords
- grass pollen, allergic rhinitis, TNSS, miniRQLQ
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
MaltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | maltodextrin powder to be taken daily Receives: Dietary Supplement: Maltodextrin |
| Probiotic | Active comparator | Probiotic blended in maltodextrin powder to be taken daily Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total nasal symptom score (TNSS)
Total nasal symptom score (TNSS) measuring nasal congestion, runny nose, nasal itching and sneezing on a scale of 0-12 will be compared over 8 weeks between the two treatment groups.
Measured: every day over 8 weeks
Secondary outcomes (6)
Total ocular symptom score (TOSS)
Measured: every day over 8 weeks
miniRQLQ
Validated rhinoconjunctivitis quality of life questionnaire (mini RQLQ) measured weekly
Measured: every week for 8 weeks
Individual nasal and ocular symptoms scores
Measured: every day over 8 weeks
Well being index
Measured: every week over 8 weeks
Medication Score
Measured: every week over 8 weeks
Specific IgE
Measured: Baseline and end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 131 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
- NCT01653652
- Sponsor's protocol ID
- 11.31. NRC
- Status last verified
- Nov 2013
- First submitted
- 27 Jul 2012
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigation of Seasonal Allergic Rhinitis Symptoms in Adults by Probiotic Intervention
- ClinicalTrials.gov ID
- NCT01653652
- Acronym / sponsor ID
- 11.31. NRC
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- grass pollen, allergic rhinitis, TNSS, miniRQLQ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 Jul 2012 (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 the current study is to evaluate the efficacy of administering a probiotic in adult human subjects suffering from allergic rhinitis during seasonal grass pollen exposure.
Detailed description
Adult subjects with documented seasonal allergic rhinitis (SAR) to grass pollen will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 8 weeks during the grass pollen allergy season. Total nasal symptom score (TNSS) will be compared over 8 weeks between the two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrinmaltodextrin powder to be taken daily |
| Probiotic | Active comparator | Dietary Supplement: ProbioticProbiotic blended in maltodextrin powder to be taken daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 to 65 years of age at the time of enrolment.
- Established seasonal allergic rhinitis (clinical history of rhinorrhea, congestion, sneezing, pruritis >2 years)
- Positive Skin Prick Test (SPT)to Grass Pollen (GP).
- Presence of specific IgE to Grass Pollen (GP)
- Have a Body Mass Index in the range 19-32 kg/m2
Key exclusion criteria (7 listed)
- Subjects currently under treatment with antibiotics or undergoing allergen immunotherapy at the time of enrolment
- Pregnancy
- Vasomotor rhinitis, nasal cavity disorders (nasal polyps), ear infections otitis media).
- Other chronic diseases (e.g. gastrointestinal, cardiovascular, infections)
- Subjects diagnosed with asthma
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 | Probiotic |
| Maltodextrin | Dietary supplement | Placebo |
Primary outcome
Total nasal symptom score (TNSS)
Time frame: every day over 8 weeks
Total nasal symptom score (TNSS) measuring nasal congestion, runny nose, nasal itching and sneezing on a scale of 0-12 will be compared over 8 weeks between the two treatment groups.
6 secondary outcomes
Total ocular symptom score (TOSS)
Time frame: every day over 8 weeks
miniRQLQ
Time frame: every week for 8 weeks
Individual nasal and ocular symptoms scores
Time frame: every day over 8 weeks
Well being index
Time frame: every week over 8 weeks
Medication Score
Time frame: every week over 8 weeks
Specific IgE
Time frame: Baseline and end of study
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 20 Nov 2013.
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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 and Maltodextrin in people with Seasonal Allergic Rhinitis, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
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 7 inclusion and 7 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 20 Nov 2013. 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 Germany. 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?
Total nasal symptom score (TNSS) (time frame: every day over 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 20 Nov 2013.