Hay FeverPROMISANCT01137357
Probiotics for Reduction Of Markers In Subjects With Allergy
A study testing Yoghurt with L. plantarum strain, Yoghurt with L.casei and Yoghurt in people with Hay Fever and Birch Pollen Allergy, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
In vitro studies reveal immunomodulatory effects of probiotic bacteria that are strain-dependent. Differential immunomodulatory in vitro capacities can not be extrapolated directly to in vivo efficacy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hay Fever, Birch Pollen Allergy
- What is being tested?
- Yoghurt with L. plantarum strain, Yoghurt with L.casei and Yoghurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2008to Dec 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- birch pollen sensitive subjects
- Positive RAST or intracutane skintest
- age 18-50
- signed informed consent form
Who cannot join
- use of probiotics
- known allergy for pets (home setting)
- use of medication influencing the immune system
- use of antibiotics
- lactose intolerance
- pregnancy
- infection
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Allergologiepraktijk Arnhem/Radboud/Rijnstate
Arnhem, Gelderland, 6824 BJ
About this study
In vitro studies reveal immunomodulatory effects of probiotic bacteria that are strain-dependent. Differential immunomodulatory in vitro capacities can not be extrapolated directly to in vivo efficacy. Thus, in vitro screening should be followed by comparative analysis of the selected immunomodulatory probiotic strains in an in vivo setting. Birch pollen allergy is one of the most common forms of respiratory allergy in European countries, and recognized by a Th2-skewed immune system. Five Lactobacillus strains will be evaluated for their immunomodulatory properties in birch pollen sensitive subjects outside the hay fever season. A double-blind placebo-controlled parallel study will be performed in which subjects with a proven birch pollen allergy will consume one of 5 different probiotic yoghurts containing 4 L. plantarum strains and 1 L. casei strain or a placebo yoghurt. Blood samples are collected at the start and after 4 weeks. Immune parameters are determined in serum and peripheral blood mononuclear cell cultures (hPBMC) derived from these subjects.
- Conditions
- Hay Fever, Birch Pollen Allergy
- Being tested
- Yoghurt with L. plantarum strain, Yoghurt with L.casei, Yoghurt
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoghurt with L. plantarum strainDietary supplement
Intake of yoghurt during 4 weeks
Yoghurt with L.caseiDietary supplement
Intake of yoghurt during 4 weeks
Yoghurt with L. plantarum strainDietary supplement
Intake of yoghurt during 4 weeks
Yoghurt with L. plantarum strainDietary supplement
Yoghurt with L. plantarum strain
Yoghurt with L. plantarum strainDietary supplement
Intake of yoghurt during 4 weeks
YoghurtDietary supplement
Intake of yoghurt during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Yoghurt with Lactobacillus strain (L.plantarum WCFS1) | Experimental | Not described Receives: Dietary Supplement: Yoghurt with L. plantarum strain |
| Yoghurt with Lactobacillus strain (L.plantarum NIZO3400) | Experimental | Not described Receives: Dietary Supplement: Yoghurt with L. plantarum strain |
| Yoghurt with Lactobacillus strain (L. plantarum NIZO2877) | Experimental | Not described Receives: Dietary Supplement: Yoghurt with L. plantarum strain |
| Yoghurt with Lactobacillus strain (L.plantarum CBS125632) | Experimental | Not described Receives: Dietary Supplement: Yoghurt with L. plantarum strain |
| Yoghurt with Lactobacillus casei Shirota | Active comparator | Not described Receives: Dietary Supplement: Yoghurt with L.casei |
| Placebo Yoghurt | Placebo comparator | Not described Receives: Dietary Supplement: Yoghurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Il-13 in PBMC after ex-vivo stimulation with birch pollen allergen (Betv1)
Secondary outcomes (1)
Other cytokines and cell-surface markers in PBMC ex vivo stimulation assay, birch pollen specific IgE, IgG and IgG4 in blood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hay FeverStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Allergologiepraktijk Arnhem/Radboud/Rijnstate, NIZO Food Research, Wageningen University, Campina Innovation
- Investigators
- A Jansen, Drs, Principal investigator, Allergologiepraktijk Arnhem/Radboud/Rijnstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137357
- Sponsor's protocol ID
- LTC 559-240908
- Acronym
- PROMISA
- Status last verified
- Jun 2010
- First submitted
- 3 Jun 2010
- Last updated
- 4 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Reduction Of Markers In Subjects With Allergy
- ClinicalTrials.gov ID
- NCT01137357
- Acronym / sponsor ID
- PROMISA / LTC 559-240908
- Conditions
- Hay Fever, Birch Pollen Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Allergologiepraktijk Arnhem/Radboud/Rijnstate, NIZO Food Research, Wageningen University, Campina Innovation
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 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.
In vitro studies reveal immunomodulatory effects of probiotic bacteria that are strain-dependent. Differential immunomodulatory in vitro capacities can not be extrapolated directly to in vivo efficacy. Thus, in vitro screening should be followed by comparative analysis of the selected immunomodulatory probiotic strains in an in vivo setting. Birch pollen allergy is one of the most common forms of respiratory allergy in European countries, and recognized by a Th2-skewed immune system. Five Lactobacillus strains will be evaluated for their immunomodulatory properties in birch pollen sensitive subjects outside the hay fever season. A double-blind placebo-controlled parallel study will be performed in which subjects with a proven birch pollen allergy will consume one of 5 different probiotic yoghurts containing 4 L. plantarum strains and 1 L. casei strain or a placebo yoghurt. Blood samples are collected at the start and after 4 weeks. Immune parameters are determined in serum and peripheral blood mononuclear cell cultures (hPBMC) derived from these subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Yoghurt with Lactobacillus strain (L.plantarum WCFS1) | Experimental | Dietary Supplement: Yoghurt with L. plantarum strain |
| Yoghurt with Lactobacillus strain (L.plantarum NIZO3400) | Experimental | Dietary Supplement: Yoghurt with L. plantarum strain |
| Yoghurt with Lactobacillus strain (L. plantarum NIZO2877) | Experimental | Dietary Supplement: Yoghurt with L. plantarum strain |
| Yoghurt with Lactobacillus strain (L.plantarum CBS125632) | Experimental | Dietary Supplement: Yoghurt with L. plantarum strain |
| Yoghurt with Lactobacillus casei Shirota | Active comparator | Dietary Supplement: Yoghurt with L.casei |
| Placebo Yoghurt | Placebo comparator | Dietary Supplement: Yoghurt |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- birch pollen sensitive subjects
- Positive RAST or intracutane skintest
- age 18-50
- signed informed consent form
Key exclusion criteria (7 listed)
- use of probiotics
- known allergy for pets (home setting)
- use of medication influencing the immune system
- use of antibiotics
- lactose intolerance
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 |
|---|---|---|
| Yoghurt with L. plantarum strainIntake of yoghurt during 4 weeks | Dietary supplement | Yoghurt with Lactobacillus strain (L.plantarum WCFS1) |
| Yoghurt with L.caseiIntake of yoghurt during 4 weeks | Dietary supplement | Yoghurt with Lactobacillus casei Shirota |
| Yoghurt with L. plantarum strainIntake of yoghurt during 4 weeks | Dietary supplement | Yoghurt with Lactobacillus strain (L.plantarum NIZO3400) |
| Yoghurt with L. plantarum strainYoghurt with L. plantarum strain | Dietary supplement | Yoghurt with Lactobacillus strain (L.plantarum CBS125632) |
| Yoghurt with L. plantarum strainIntake of yoghurt during 4 weeks | Dietary supplement | Yoghurt with Lactobacillus strain (L. plantarum NIZO2877) |
| YoghurtIntake of yoghurt during 4 weeks | Dietary supplement | Placebo Yoghurt |
Primary outcome
Il-13 in PBMC after ex-vivo stimulation with birch pollen allergen (Betv1)
1 secondary outcome
Other cytokines and cell-surface markers in PBMC ex vivo stimulation assay, birch pollen specific IgE, IgG and IgG4 in blood
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 4 Jun 2010.
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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.
A Jansen, Drs principal investigator
Allergologiepraktijk Arnhem/Radboud/Rijnstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoghurt with L. plantarum strain, Yoghurt with L.casei and Yoghurt in people with Hay Fever and Birch Pollen Allergy, run by Rijnstate Hospital at 1 site in Netherlands.
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 4 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 4 Jun 2010. 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 Netherlands. 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?
Il-13 in PBMC after ex-vivo stimulation with birch pollen allergen (Betv1). 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 4 Jun 2010.