Allergic RhinitisPhase 3NCT04637425

Effect of Bacterial Lysate on Nasal Carriage of Staphylococcus Aureus

A Phase 3 study testing Ismigen in people with Allergic Rhinitis, run by Medical University of Lublin at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study assesses the effectiveness of Polyvalent Mechanical Bacterial Lysate (PMBL-Ismigen) in reducing nasal methicillin-resistant Staphylococcus aureus (MRSA) colony growth in children with pollen allergic rhinitis (AR) aged 5 to 17. Half of the participants received PMBL and the other half received a placebo. Read more about this study

Who is it for?: Ages 5 to 17 years
Conditions the study is for: Allergic Rhinitis
What is being tested?: Ismigen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 sitePoland
Study dates: 22 Apr 2018to 31 Aug 2020
Phase: Phase 3
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 5 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children of both genders aged 5 to 17 years.
Children with grass pollen-induced allergic rhinitis recognized and treated according to current ARIA (Allergic Rhinitis and its Impact on Asthma) recommendations.
Positive skin prick test to grass pollen allergens or positive specific IgE (defined as ≥ class 2, ≥ 0,70 kU/l) against timothy grass pollen allergens.
Presentation of clinical symptoms of the allergic rhinitis (rhinorrhea, nasal congestion, nasal itching, sneezing) in at least two recent grass pollen seasons in Poland before inclusion in the study.
Proper use of polyvalent mechanical bacterial lysate sublingual tablets.
Written informed consent obtained from parents/guardians before any study related procedures are performed.

Who cannot join

Patient received mechanical or any other polyvalent bacterial lysate immunostimulation within the previous 12 months before randomisation visit.
Patient received oral/subcutaneous allergen-immunotherapy within the previous 3 years before the start of the study.
Vaccination performed within 3 months before the beginning of the study.
Deficiencies in cellular and humoral immunity.
Treatment with antibiotics within the last 1 month before the start of the study.
Treatment with systemic corticosteroids within the last 6 months before the start of the study.
Pregnant or breastfeeding woman.
Other chronic conditions of the nose or nasal sinuses.

Trial locations and contacts

1 site in 1 country.

Poland1 site

Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin
Lublin, 20-093

Other trials in Poland

About this study

Official title: The Effect of Polyvalent Mechanical Bacterial Lysate on the Reduction of Nasal Staphylococcus Aureus Carriage in Children With Pollen Allergic Rhinitis

Read the detailed description

Seasonal allergic rhinitis (SAR) is caused by the allergens of wind-pollinated plants, and in Poland mainly by grass pollen allergens. During the grass pollen season, patients may suffer from fatigue, weakness, lack of fitness, difficulty in sleeping and reduced performance at school. In people allergic to the above-mentioned pollen, the disease significantly reduces the quality of life and requires intensive treatment in the pollen period.

MRSA colonizing the nasal cavity has the ability to actively modulate the immune response in children suffering from SAR. Many studies have shown a greater severity of AR symptoms in patients with a MRSA-positive nasal swab compared to patients with normal nasal flora.

Due to the high incidence of AR, the negative impact of the disease on the quality of life, and incomplete effectiveness of previously available therapeutic methods, new methods of treatment are being developed. Recent research highlights the immunoregulatory potential of bacterial lysates, indicating the possibility of their future use in the prevention and treatment of allergic diseases, including atopic dermatitis, AR, and asthma.

Based on the above considerations, it can be hypothesized that bacterial lysates reduce the severity of AR symptoms by eradicating MRSA from the nasal cavity. However, so far no randomized, double-blind, placebo-controlled study has been conducted to evaluate the effect of bacterial lysates on nasal Staphylococcus aureus carriage in children with SAR.

The main aim of this study was to evaluate nasal colonization by MRSA among children with SAR and the effect of PMBL on the reduction of MRSA colony growth in these children.

70 children with SAR were enrolled to this study and were randomly assigned to the PMBL group (n=35) and placebo group (n=35). Two visits took place as part of the study: at the beginning of the grass pollen season and at the end of the season. The time frame of the grass pollen season for south-eastern Poland was determined using the "95%" method on the basis of measurements of grass pollen concentration in the atmospheric air, which were obtained from the Environmental Allergy Research Centre in Warsaw. Nasal swabs for bacteriological cultures were taken at each visit and were transferred to the hospital laboratory.

Conditions: Allergic Rhinitis
Being tested: Ismigen, Placebo
Keywords: allergic rhinitis, seasonal allergic rhinitis, children, grass pollen season, bacterial lysate, nasal Staphylococcus aureus carriage
Medical subject headings: Rhinitis, Allergic, Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IsmigenDrug
Also called Polyvalent Mechanical Bacterial Lysate (PMBL)
Sublingual tablets containing 7 mg of bacterial lysate from the following bacteria: Staphylococcus aureus, Haemophilus influenzae serotype B, Klebsiella pneumoniae, Klebsiella ozaenae, Neiserria catarrhalis, Streptococcus viridans, Streptococcus pyogenes, Streptococcus pneumoniae (6 strains: TY1/EQ11, TY2/EQ22, TY3/EQ14, TY5/EQ15, TY8/EQ23, TY47/EQ24) - sublingual use 1 tablet per day over 10 days for 3 successive months.
PlaceboDrug
Matched tablets without any active substance.

Study groups in NCT04637425
Study group	Role	What they receive
Ismigen	Experimental	Treatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest. Receives: Drug: Ismigen
Placebo	Placebo comparator	Treatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the growth intensity of the nasal Staphylococcus aureus colony
At the randomization visit and end-of-study visit, a nasal swab was collected for bacteriological cultures and compared whether there was a change in the growth intensity of the Staphylococcus aureus colony between these two points.
The collected material was placed in a test-tube with a transport medium and transferred to the laboratory of the University Children's Hospital in Lublin, where it was inoculated on appropriate media. Microbial growth was assessed by semi-quantitative method (+ scanty growth, ++ moderate growth, +++ large growth, ++++ abundant growth).
Measured: at baseline, and at 3-months

Secondary outcomes (6)

Incidence of treatment emergent adverse events [safety and tolerability]
Incidence, frequency and severity of treatment emergent adverse events.
Measured: from baseline, up to the 3-month time point
Incidence of treatment emergent adverse events leading to discontinuation [safety and tolerability]
The number of participants with adverse events leading to discontinuation.
Measured: from baseline, up to the 3-month time point
Time to discontinuation due to treatment emergent adverse events [safety and tolerability]
To assess the time that has elapsed since treatment initiation to the occurrence of an adverse event leading to discontinuation.
Measured: From date of randomization until the date of occurrence of an adverse event leading to discontinuation, assessed up to 3 months
Incidence of treatment emergent abnormalities in physical examination findings [safety and tolerability]
Observe skin, lymph nodes, ears, eyes, nose, throat, cardiac and pulmonary status, abdomen and extremities for any abnormalities.
Measured: at baseline, and at 3-months
Incidence of treatment emergent abnormalities in pulse rate [safety and tolerability]
Measure resting pulse rate as beats per minute.
Measured: at baseline, and at 3-months
Incidence of treatment emergent abnormalities in blood pressure [safety and tolerability]
Measure systolic and diastolic blood pressure (in mmHg).
Measured: at baseline, and at 3-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 201831 Aug 2020

First posted19 Nov 2020
Study start22 Apr 2018
Primary completion31 Aug 2020
Study completion31 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Allergic RhinitisStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04637425
Sponsor's protocol ID: KE-0254/41/2018(2)
Status last verified: Dec 2020
First submitted: 15 Nov 2020
Last updated: 11 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Janeczek K, Emeryk A, Rachel M, Duma D, Zimmer L, Poleszak E. Polyvalent Mechanical Bacterial Lysate Administration Improves the Clinical Course of Grass Pollen-Induced Allergic Rhinitis in Children: A Randomized Controlled Trial. J Allergy Clin Immunol Pract. 2021 Jan;9(1):453-462. doi: 10.1016/j.jaip.2020.08.025. Epub 2020 Aug 26.
PubMed 32858239
Janeczek KP, Emeryk A, Rapiejko P. Effect of polyvalent bacterial lysate on the clinical course of pollen allergic rhinitis in children. Postepy Dermatol Alergol. 2019 Aug;36(4):504-505. doi: 10.5114/ada.2019.87457. Epub 2019 Aug 30. No abstract available.
PubMed 31616231
Banche G, Allizond V, Mandras N, Garzaro M, Cavallo GP, Baldi C, Scutera S, Musso T, Roana J, Tullio V, Carlone NA, Cuffini AM. Improvement of clinical response in allergic rhinitis patients treated with an oral immunostimulating bacterial lysate: in vivo immunological effects. Int J Immunopathol Pharmacol. 2007 Jan-Mar;20(1):129-38. doi: 10.1177/039463200702000115.
PubMed 17346436
Meng Q, Li P, Li Y, Chen J, Wang L, He L, Xie J, Gao X. Broncho-vaxom alleviates persistent allergic rhinitis in patients by improving Th1/Th2 cytokine balance of nasal mucosa. Rhinology. 2019 Dec 1;57(6):451-459. doi: 10.4193/Rhin19.161.
PubMed 31403136
Han L, Zheng CP, Sun YQ, Xu G, Wen W, Fu QL. A bacterial extract of OM-85 Broncho-Vaxom prevents allergic rhinitis in mice. Am J Rhinol Allergy. 2014 Mar-Apr;28(2):110-6. doi: 10.2500/ajra.2013.27.4021.
PubMed 24717947
Liu C, Huang R, Yao R, Yang A. The Immunotherapeutic Role of Bacterial Lysates in a Mouse Model of Asthma. Lung. 2017 Oct;195(5):563-569. doi: 10.1007/s00408-017-0003-8. Epub 2017 May 4.
PubMed 28474108
Esposito S, Soto-Martinez ME, Feleszko W, Jones MH, Shen KL, Schaad UB. Nonspecific immunomodulators for recurrent respiratory tract infections, wheezing and asthma in children: a systematic review of mechanistic and clinical evidence. Curr Opin Allergy Clin Immunol. 2018 Jun;18(3):198-209. doi: 10.1097/ACI.0000000000000433.
PubMed 29561355
Emeryk A, Bartkowiak-Emeryk M, Raus Z, Braido F, Ferlazzo G, Melioli G. Mechanical bacterial lysate administration prevents exacerbation in allergic asthmatic children-The EOLIA study. Pediatr Allergy Immunol. 2018 Jun;29(4):394-401. doi: 10.1111/pai.12894.
PubMed 29575037
Refaat MM, Ahmed TM, Ashour ZA, Atia MY. Immunological role of nasal staphylococcus aureus carriage in patients with persistent allergic rhinitis. Pan Afr Med J. 2008 Oct 30;1:3.
PubMed 21532892
Hohchi N, Hashida K, Ohkubo J, Wakasugi T, Mori T, Nguyen KH, Kuroda E, Ikeno T, Taniguchi H, Suzuki H. Synergism of Staphylococcus aureus colonization and allergic reaction in the nasal cavity in mice. Int Arch Allergy Immunol. 2012;159(1):33-40. doi: 10.1159/000335200. Epub 2012 May 3.
PubMed 22555155
Cevik C, Yula E, Yengil E, Gulmez MI, Akbay E. Identification of nasal bacterial flora profile and carriage rates of methicillin-resistant Staphylococcus aureus in patients with allergic rhinitis. Eur Arch Otorhinolaryngol. 2014 Jan;271(1):103-7. doi: 10.1007/s00405-013-2492-2. Epub 2013 Apr 17.
PubMed 23591798
Shiomori T, Yoshida S, Miyamoto H, Makishima K. Relationship of nasal carriage of Staphylococcus aureus to pathogenesis of perennial allergic rhinitis. J Allergy Clin Immunol. 2000 Mar;105(3):449-54. doi: 10.1067/mai.2000.104256.
PubMed 10719292
Zagolski O, Strek P, Kasprowicz A, Bialecka A. Effectiveness of Polyvalent Bacterial Lysate and Autovaccines Against Upper Respiratory Tract Bacterial Colonization by Potential Pathogens: A Randomized Study. Med Sci Monit. 2015 Oct 5;21:2997-3002. doi: 10.12659/MSM.893779.
PubMed 26434686
Janeczek K, Emeryk A, Zimmer L, Poleszak E, Ordak M. Nasal carriage of Staphylococcus aureus in children with grass pollen-induced allergic rhinitis and the effect of polyvalent mechanical bacterial lysate immunostimulation on carriage status: A randomized controlled trial. Immun Inflamm Dis. 2022 Mar;10(3):e584. doi: 10.1002/iid3.584. Epub 2021 Dec 29.
PubMed 34965026

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Polyvalent Mechanical Bacterial Lysate on the Reduction of Nasal Staphylococcus Aureus Carriage in Children With Pollen Allergic Rhinitis
ClinicalTrials.gov ID: NCT04637425
Acronym / sponsor ID: KE-0254/41/2018(2)
Conditions: Allergic Rhinitis
Keywords: allergic rhinitis, seasonal allergic rhinitis, children, grass pollen season, bacterial lysate, nasal Staphylococcus aureus carriage
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Medical University of LublinUniversity, hospital or other
Study start: 22 Apr 2018 (actual)
Primary completion: 31 Aug 2020 (actual)
Study completion: 31 Aug 2020 (actual)
First posted: 19 Nov 2020 (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.

Detailed description

The main aim of this study was to evaluate nasal colonization by MRSA among children with SAR and the effect of PMBL on the reduction of MRSA colony growth in these children.

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
Ismigen	Experimental	Drug: IsmigenTreatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest.
Placebo	Placebo comparator	Drug: PlaceboTreatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest.

Who may qualify

Ages: 5 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Children of both genders aged 5 to 17 years.
Children with grass pollen-induced allergic rhinitis recognized and treated according to current ARIA (Allergic Rhinitis and its Impact on Asthma) recommendations.
Positive skin prick test to grass pollen allergens or positive specific IgE (defined as ≥ class 2, ≥ 0,70 kU/l) against timothy grass pollen allergens.
Presentation of clinical symptoms of the allergic rhinitis (rhinorrhea, nasal congestion, nasal itching, sneezing) in at least two recent grass pollen seasons in Poland before inclusion in the study.
Proper use of polyvalent mechanical bacterial lysate sublingual tablets.

Key exclusion criteria (8 listed)

Patient received mechanical or any other polyvalent bacterial lysate immunostimulation within the previous 12 months before randomisation visit.
Patient received oral/subcutaneous allergen-immunotherapy within the previous 3 years before the start of the study.
Vaccination performed within 3 months before the beginning of the study.
Deficiencies in cellular and humoral immunity.
Treatment with antibiotics within the last 1 month before the start of the study.

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
IsmigenAlso: Polyvalent Mechanical Bacterial Lysate (PMBL)Sublingual tablets containing 7 mg of bacterial lysate from the following bacteria: Staphylococcus aureus, Haemophilus influenzae serotype B, Klebsiella pneumoniae, Klebsiella ozaenae, Neiserria catarrhalis, Streptococcus viridans, Streptococcus pyogenes, Streptococcus pneumoniae (6 strains: TY1/EQ11, TY2/EQ22, TY3/EQ14, TY5/EQ15, TY8/EQ23, TY47/EQ24) - sublingual use 1 tablet per day over 10 days for 3 successive months.	Drug	Ismigen
PlaceboMatched tablets without any active substance.	Drug	Placebo

Primary outcome

Change in the growth intensity of the nasal Staphylococcus aureus colony
Time frame: at baseline, and at 3-months
At the randomization visit and end-of-study visit, a nasal swab was collected for bacteriological cultures and compared whether there was a change in the growth intensity of the Staphylococcus aureus colony between these two points. The collected material was placed in a test-tube with a transport medium and transferred to the laboratory of the University Children's Hospital in Lublin, where it was inoculated on appropriate media. Microbial growth was assessed by semi-quantitative method (+ scanty growth, ++ moderate growth, +++ large growth, ++++ abundant growth).

6 secondary outcomes

Incidence of treatment emergent adverse events [safety and tolerability]
Time frame: from baseline, up to the 3-month time point
Incidence of treatment emergent adverse events leading to discontinuation [safety and tolerability]
Time frame: from baseline, up to the 3-month time point
Time to discontinuation due to treatment emergent adverse events [safety and tolerability]
Time frame: From date of randomization until the date of occurrence of an adverse event leading to discontinuation, assessed up to 3 months
Incidence of treatment emergent abnormalities in physical examination findings [safety and tolerability]
Time frame: at baseline, and at 3-months
Incidence of treatment emergent abnormalities in pulse rate [safety and tolerability]
Time frame: at baseline, and at 3-months
Incidence of treatment emergent abnormalities in blood pressure [safety and tolerability]
Time frame: at baseline, and at 3-months

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 11 Apr 2022.
Background: PubMed 32858239Janeczek K, Emeryk A, Rachel M, Duma D, Zimmer L, Poleszak E. Polyvalent Mechanical Bacterial Lysate Administration Improves the Clinical Course of Grass Pollen-Induced Allergic Rhinitis in Children: A Randomized Controlled Trial. J Allergy Clin Immunol Pract. 2021 Jan;9(1):453-462. doi: 10.1016/j.jaip.2020.08.025. Epub 2020 Aug 26.
Background: PubMed 31616231Janeczek KP, Emeryk A, Rapiejko P. Effect of polyvalent bacterial lysate on the clinical course of pollen allergic rhinitis in children. Postepy Dermatol Alergol. 2019 Aug;36(4):504-505. doi: 10.5114/ada.2019.87457. Epub 2019 Aug 30. No abstract available.
Background: PubMed 17346436Banche G, Allizond V, Mandras N, Garzaro M, Cavallo GP, Baldi C, Scutera S, Musso T, Roana J, Tullio V, Carlone NA, Cuffini AM. Improvement of clinical response in allergic rhinitis patients treated with an oral immunostimulating bacterial lysate: in vivo immunological effects. Int J Immunopathol Pharmacol. 2007 Jan-Mar;20(1):129-38. doi: 10.1177/039463200702000115.
Background: PubMed 31403136Meng Q, Li P, Li Y, Chen J, Wang L, He L, Xie J, Gao X. Broncho-vaxom alleviates persistent allergic rhinitis in patients by improving Th1/Th2 cytokine balance of nasal mucosa. Rhinology. 2019 Dec 1;57(6):451-459. doi: 10.4193/Rhin19.161.
Background: PubMed 24717947Han L, Zheng CP, Sun YQ, Xu G, Wen W, Fu QL. A bacterial extract of OM-85 Broncho-Vaxom prevents allergic rhinitis in mice. Am J Rhinol Allergy. 2014 Mar-Apr;28(2):110-6. doi: 10.2500/ajra.2013.27.4021.
Background: PubMed 28474108Liu C, Huang R, Yao R, Yang A. The Immunotherapeutic Role of Bacterial Lysates in a Mouse Model of Asthma. Lung. 2017 Oct;195(5):563-569. doi: 10.1007/s00408-017-0003-8. Epub 2017 May 4.
Background: PubMed 29561355Esposito S, Soto-Martinez ME, Feleszko W, Jones MH, Shen KL, Schaad UB. Nonspecific immunomodulators for recurrent respiratory tract infections, wheezing and asthma in children: a systematic review of mechanistic and clinical evidence. Curr Opin Allergy Clin Immunol. 2018 Jun;18(3):198-209. doi: 10.1097/ACI.0000000000000433.
Background: PubMed 29575037Emeryk A, Bartkowiak-Emeryk M, Raus Z, Braido F, Ferlazzo G, Melioli G. Mechanical bacterial lysate administration prevents exacerbation in allergic asthmatic children-The EOLIA study. Pediatr Allergy Immunol. 2018 Jun;29(4):394-401. doi: 10.1111/pai.12894.
Background: PubMed 21532892Refaat MM, Ahmed TM, Ashour ZA, Atia MY. Immunological role of nasal staphylococcus aureus carriage in patients with persistent allergic rhinitis. Pan Afr Med J. 2008 Oct 30;1:3.
Background: PubMed 22555155Hohchi N, Hashida K, Ohkubo J, Wakasugi T, Mori T, Nguyen KH, Kuroda E, Ikeno T, Taniguchi H, Suzuki H. Synergism of Staphylococcus aureus colonization and allergic reaction in the nasal cavity in mice. Int Arch Allergy Immunol. 2012;159(1):33-40. doi: 10.1159/000335200. Epub 2012 May 3.
Background: PubMed 23591798Cevik C, Yula E, Yengil E, Gulmez MI, Akbay E. Identification of nasal bacterial flora profile and carriage rates of methicillin-resistant Staphylococcus aureus in patients with allergic rhinitis. Eur Arch Otorhinolaryngol. 2014 Jan;271(1):103-7. doi: 10.1007/s00405-013-2492-2. Epub 2013 Apr 17.
Background: PubMed 10719292Shiomori T, Yoshida S, Miyamoto H, Makishima K. Relationship of nasal carriage of Staphylococcus aureus to pathogenesis of perennial allergic rhinitis. J Allergy Clin Immunol. 2000 Mar;105(3):449-54. doi: 10.1067/mai.2000.104256.

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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 Phase 3 study testing Ismigen in people with Allergic Rhinitis, run by Medical University of Lublin at 1 site in Poland.

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 8 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 11 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 Poland. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change in the growth intensity of the nasal Staphylococcus aureus colony (time frame: at baseline, and at 3-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04637425, which also lists 14 linked publications.

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 11 Apr 2022.