Allergic RhinoconjunctivitisNCT04898686
Probiotic Chewables in Allergic Rhinoconjunctivitis Patients
A study testing Probiotic chewables in people with Allergic Rhinoconjunctivitis, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
With this double- blind, randomised, placebo-controlled study, the investigators want to investigate the influence of a chewable with the probiotic strain Lacticaseibacillus rhamnosus GG on the symptoms and immunological markers of allergic rhinoconjunctivitis (AR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- Probiotic chewables
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2020to 6 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 at the time of registration;
- Seasonal allergic rhinoconjunctivitis (AR) in the context of grass pollen allergy diagnosed on the basis of anamnesis cfr. ARIA guidelines and positive skin prick test and / or immunocap assay;
- Positive skin prick test (SPT) for grass pollen and / or the presence of specific IgE for grass pollen, confirmed by a medical specialist, measured at the start of the study: Soluprick SQ Phleum pratense pollen 10 HEP - ALK and / or IgE specific immunocap assay Phleum pratense (timothy grass) (g6);
- Body Mass Index in the range of 19-32 kg / m2;
- Instructed during screening and agreed not to use other probiotic products outside of the study during the study period;
- Signed the consent form.
Who cannot join
- Antibiotic use at baseline and during the study;
- Pregnant women;
- Unstable / uncontrolled asthma (to be determined by investigator-physician);
- Sensitization to dust mites
- History of probiotic use in the past two weeks;
- Current diagnosis of cancer or immunosuppressive therapy within the past 6 months;
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- Abnormalities of the oral mucosa;
- Acute and chronic infectious and inflammatory upper airway diseases (eg acute / chronic rhinosinusitis cfr. EPOS guidelines);
- Clinically significant bleeding disorder;
- Any other medical condition that, in the principal investigator's opinion, warrants exclusion from the trial;
- History of regular use (> 3 days out of 7) of tobacco products within the previous two weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Probiotic Potential of a Lacticaseibacillus Strain in the Upper Airways in Patients With Allergic Rhinoconjunctivitis After Administration in a Chewable
With this double- blind, randomised, placebo-controlled study, the investigators want to investigate the influence of a chewable with the probiotic strain Lacticaseibacillus rhamnosus GG on the symptoms and immunological markers of allergic rhinoconjunctivitis (AR). In addition, the investigators aim to study the influence of this probiotic chewable on the microbiome of the upper respiratory tract after administration in adults with AR. The bacterial and cytokine profiles in the naso- and oropharynx will be monitored before, during and after the treatment.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Probiotic chewables, Placebo chewables
- Keywords
- lactobacilli, microbiome, probiotic chewables
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic chewablesBiological
chewables containing Lacticaseibacillus rhamnosus GG
Placebo chewablesBiological
chewables without probiotic strain. Ingredients: Xylitol, microcrystalline cellulose, stearic acid, natural orange flavor, silica, magnesium stearate, citric acid and malic acid.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | daily use of a probiotic chewable for 8 weeks Receives: Biological: Probiotic chewables |
| Placebo group | Placebo comparator | daily use of the placebo chewable for 8 weeks Receives: Biological: Placebo chewables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfer of L. rhamnosus GG (estimated CFU counts) to the oronasopharyngeal cavity after administration of the chewable
qPCR
Measured: at 8 weeks
Changes in the score of allergic rhinitis symptoms
Daily questionnaires will be used, in which a self-reported Total Nasal Symptom Score (TNSS) based on rhinorrhea, nasal congestion, nasal itching and sneezing with symptom severity ranging from 0 (no problem) to 12 (very severe problem) will be recorded.
Measured: over the study period (= 10 weeks)
Secondary outcomes (5)
changes in microbiome of the oronasopharyngeal region after administration of the chewable
16S rRNA amplicon sequencing
Measured: baseline, 8 weeks
Inlfuence on general nose- and mouth health
A clinical evaluation by an ENT specialist will be performed at the start and 8 weeks of the study to assess the general nose and mouth health of the participants. Questions on discomfort and symptoms of inflammation or infection in the nose and mouth will be included in the Sino-Nasal Outcome Test (SNOT-22)-based questionnaire implemented at the start, week 8 and week 10. Symptoms will be scored from 0 (no problem) to 5 (very severe problem)
Measured: baseline, 8 weeks, 10 weeks
Changes in the absolute numbers of specific airway pathogens and viruses
qPCR
Measured: baseline, 8 weeks
Changes in cytokine levels (e.g. IL-10, IL-4, IL-5, IL-13) in oro- and nasopharynx samples, and cytokine and antibody levels in blood samples
qPCR and/or ELISA
Measured: baseline, 8 weeks
Frequency of medication use
Daily questionnaires will be used where the type and frequency of medication use should be recorded
Measured: over the study period (= 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Aug 2020
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinoconjunctivitisStudies 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
- Model description
- double blind, randomized, placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Sarah Lebeer, University Hospital, Antwerp
- Investigators
- Sarah Lebeer, Prof, Principal investigator, Universiteit AntwerpenOlivier Vanderveken, Prof, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898686
- Sponsor's protocol ID
- B3002020000086
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Probiotic Potential of a Lacticaseibacillus Strain in the Upper Airways in Patients With Allergic Rhinoconjunctivitis After Administration in a Chewable
- ClinicalTrials.gov ID
- NCT04898686
- Acronym / sponsor ID
- B3002020000086
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- lactobacilli, microbiome, probiotic chewables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 24 May 2021 (actual)
- 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.
With this double- blind, randomised, placebo-controlled study, the investigators want to investigate the influence of a chewable with the probiotic strain Lacticaseibacillus rhamnosus GG on the symptoms and immunological markers of allergic rhinoconjunctivitis (AR). In addition, the investigators aim to study the influence of this probiotic chewable on the microbiome of the upper respiratory tract after administration in adults with AR. The bacterial and cytokine profiles in the naso- and oropharynx will be monitored before, during and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind, randomized, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Active comparator | Biological: Probiotic chewablesdaily use of a probiotic chewable for 8 weeks |
| Placebo group | Placebo comparator | Biological: Placebo chewablesdaily use of the placebo chewable for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 at the time of registration;
- Seasonal allergic rhinoconjunctivitis (AR) in the context of grass pollen allergy diagnosed on the basis of anamnesis cfr. ARIA guidelines and positive skin prick test and / or immunocap assay;
- Positive skin prick test (SPT) for grass pollen and / or the presence of specific IgE for grass pollen, confirmed by a medical specialist, measured at the start of the study: Soluprick SQ Phleum pratense pollen 10 HEP - ALK and / or IgE specific immunocap assay Phleum pratense (timothy grass) (g6);
- Body Mass Index in the range of 19-32 kg / m2;
- Instructed during screening and agreed not to use other probiotic products outside of the study during the study period;
Key exclusion criteria (11 listed)
- Antibiotic use at baseline and during the study;
- Pregnant women;
- Unstable / uncontrolled asthma (to be determined by investigator-physician);
- Sensitization to dust mites
- History of probiotic use in the past two weeks;
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 chewableschewables containing Lacticaseibacillus rhamnosus GG | Biological | Probiotic group |
| Placebo chewableschewables without probiotic strain. Ingredients: Xylitol, microcrystalline cellulose, stearic acid, natural orange flavor, silica, magnesium stearate, citric acid and malic acid. | Biological | Placebo group |
Primary outcome
Transfer of L. rhamnosus GG (estimated CFU counts) to the oronasopharyngeal cavity after administration of the chewable
Time frame: at 8 weeks
qPCR
Changes in the score of allergic rhinitis symptoms
Time frame: over the study period (= 10 weeks)
Daily questionnaires will be used, in which a self-reported Total Nasal Symptom Score (TNSS) based on rhinorrhea, nasal congestion, nasal itching and sneezing with symptom severity ranging from 0 (no problem) to 12 (very severe problem) will be recorded.
5 secondary outcomes
changes in microbiome of the oronasopharyngeal region after administration of the chewable
Time frame: baseline, 8 weeks
Inlfuence on general nose- and mouth health
Time frame: baseline, 8 weeks, 10 weeks
Changes in the absolute numbers of specific airway pathogens and viruses
Time frame: baseline, 8 weeks
Changes in cytokine levels (e.g. IL-10, IL-4, IL-5, IL-13) in oro- and nasopharynx samples, and cytokine and antibody levels in blood samples
Time frame: baseline, 8 weeks
Frequency of medication use
Time frame: over the study period (= 10 weeks)
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 15 Apr 2022.
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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.
Sarah Lebeer, Prof principal investigator
Universiteit Antwerpen
Olivier Vanderveken, Prof principal investigator
University Hospital, Antwerp
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 chewables in people with Allergic Rhinoconjunctivitis, run by University Hospital, Antwerp at 1 site in Belgium.
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 6 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 15 Apr 2022. 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 Belgium. 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?
Transfer of L. rhamnosus GG (estimated CFU counts) to the oronasopharyngeal cavity after administration of the chewable (time frame: at 8 weeks). 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 15 Apr 2022.