Effect of Bacterial Lysate on Nasal Carriage of Staphylococcus Aureus

NCT04637425 | Completed Phase 3

• 1 other identifier: KE-0254/41/2018(2)
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergic Rhinitis

Keywords

allergic rhinitis; seasonal allergic rhinitis; children; grass pollen season; bacterial lysate; nasal Staphylococcus aureus carriage

Outcome Measures

Primary Outcomes (1)

• 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).

  at baseline, and at 3-months

Secondary Outcomes (6)

• Incidence of treatment emergent adverse events [safety and tolerability]

  from baseline, up to the 3-month time point

• Incidence of treatment emergent adverse events leading to discontinuation [safety and tolerability]

  from baseline, up to the 3-month time point

• Time to discontinuation due to treatment emergent adverse events [safety and tolerability]

  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]

  at baseline, and at 3-months

• Incidence of treatment emergent abnormalities in pulse rate [safety and tolerability]

  at baseline, and at 3-months

Study Arms (2)

Ismigen

EXPERIMENTAL

Treatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest.

Drug: Ismigen

Placebo

PLACEBO COMPARATOR

Treatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest.

Drug: Placebo

Interventions

Ismigen DRUG

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.

Also known as: Polyvalent Mechanical Bacterial Lysate (PMBL)

Ismigen

Placebo DRUG

Matched tablets without any active substance.

Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Proper use of polyvalent mechanical bacterial lysate sublingual tablets.
• Written informed consent obtained from parents/guardians before any study related procedures are performed.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin

Lublin, 20-093, Poland

Location

Related Publications (14)

• 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.

  PMID: 32858239 BACKGROUND

• 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.

  PMID: 31616231 BACKGROUND

• 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.

  PMID: 17346436 BACKGROUND

• 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.

  PMID: 31403136 BACKGROUND

• 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.

  PMID: 24717947 BACKGROUND

• 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.

  PMID: 28474108 BACKGROUND

• 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.

  PMID: 29561355 BACKGROUND

• 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.

  PMID: 29575037 BACKGROUND

• 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.

  PMID: 21532892 BACKGROUND

• 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.

  PMID: 22555155 BACKGROUND

• 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.

  PMID: 23591798 BACKGROUND

• 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.

  PMID: 10719292 BACKGROUND

• 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.

  PMID: 26434686 BACKGROUND

• 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.

  PMID: 34965026 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Interventions

Broncho-Vaxom

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: November 19, 2020
• Study Start: April 22, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: April 11, 2022

Record last verified: 2020-12

Locations

PL (1)