Rhinitis, Allergic, SeasonalPhase 1/2NCT00746226
Probiotics for Birch Pollen Allergy
A Phase 1/2 study testing Lactobacillus acidophilus and Bifidobacterium lactis in people with Rhinitis, Allergic, Seasonal, run by Danisco at 1 site in Finland.
Trial summary
Birch pollen allergy is one of the most common forms of respiratory allergy in the Nordic countries. Treatment consists of antihistamine use. Specific probiotic strains have been observed to modulate the immune system. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- Lactobacillus acidophilus and Bifidobacterium lactis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2006to Feb 2007
- Phase
- Phase 1/2
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Physician verified birch pollen allergy
Who cannot join
- Diagnosed asthma Habitual use of probiotics and/or prebiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotic Intervention for Children With Birch Pollen Allergy
Birch pollen allergy is one of the most common forms of respiratory allergy in the Nordic countries. Treatment consists of antihistamine use. Specific probiotic strains have been observed to modulate the immune system. Since the body has a common mucosal immune system; it was hypothesised that consumption of probiotics may affect also the respiratory mucosal immune response and hence affect respiratory allergy.
Earlier studies with probiotics had been unable to show improvements in adults with pollen allergy. It was therefore hypothesised that children, who's immune system is not yet fully developed, might be better targets.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- Lactobacillus acidophilus and Bifidobacterium lactis, Placebo
- Keywords
- birch pollen
- 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.
Lactobacillus acidophilus and Bifidobacterium lactisBiological
Daily 5x10^9 CFU of a combination of L. acidophilus and B. lactis
PlaceboBiological
Microcrystalline cellulose
As capsule which could be opened
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Numbers 509-513, 700-709 and 900-909 Probiotic combination of L. acidophilus and B. lactis Receives: Biological: Lactobacillus acidophilus and Bifidobacterium lactis |
| B | Placebo comparator | Numbers 612-624 and 800-811
Microcrystalline cellulose Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birch pollen allergy symptoms
Measured: March/April and June
Nasal Eosinophilia
Measured: April/May and June
Secondary outcomes (3)
Change in microbiota composition
Measured: April/May and June
Cytokine profile from serum
Measured: April/May and June
Faecal recovery of administered probiotics
Measured: April/May and June
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startMar 2006
- Primary completionJun 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, SeasonalStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Arthur C Ouwehand, PhD, Study chair, Danisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746226
- Sponsor's protocol ID
- Danisco - TBPA06
- Status last verified
- Sep 2008
- First submitted
- 2 Sep 2008
- Last updated
- 3 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Intervention for Children With Birch Pollen Allergy
- ClinicalTrials.gov ID
- NCT00746226
- Acronym / sponsor ID
- Danisco - TBPA06
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- birch pollen
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jun 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 3 Sep 2008 (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.
Birch pollen allergy is one of the most common forms of respiratory allergy in the Nordic countries. Treatment consists of antihistamine use. Specific probiotic strains have been observed to modulate the immune system. Since the body has a common mucosal immune system; it was hypothesised that consumption of probiotics may affect also the respiratory mucosal immune response and hence affect respiratory allergy.
Earlier studies with probiotics had been unable to show improvements in adults with pollen allergy. It was therefore hypothesised that children, who's immune system is not yet fully developed, might be better targets.
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 |
|---|---|---|
| A | Active comparator | Biological: Lactobacillus acidophilus and Bifidobacterium lactisNumbers 509-513, 700-709 and 900-909 Probiotic combination of L. acidophilus and B. lactis |
| B | Placebo comparator | Biological: PlaceboNumbers 612-624 and 800-811 Microcrystalline cellulose |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Physician verified birch pollen allergy
Key exclusion criteria (1 listed)
- Diagnosed asthma Habitual use of probiotics and/or prebiotics
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 acidophilus and Bifidobacterium lactisDaily 5x10^9 CFU of a combination of L. acidophilus and B. lactis | Biological | A |
| PlaceboMicrocrystalline cellulose As capsule which could be opened | Biological | B |
Primary outcome
Birch pollen allergy symptoms
Time frame: March/April and June
Nasal Eosinophilia
Time frame: April/May and June
3 secondary outcomes
Change in microbiota composition
Time frame: April/May and June
Cytokine profile from serum
Time frame: April/May and June
Faecal recovery of administered probiotics
Time frame: April/May and June
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 3 Sep 2008.
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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.
Arthur C Ouwehand, PhD study chair
Danisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lactobacillus acidophilus and Bifidobacterium lactis in people with Rhinitis, Allergic, Seasonal, run by Danisco at 1 site in Finland.
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 1 inclusion and 1 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 3 Sep 2008. 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 Finland. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Birch pollen allergy symptoms (time frame: March/April and June). The study lists 2 primary outcomes in all. 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 3 Sep 2008; AzTrials last refreshed its copy on 29 Oct 2026.