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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05063149
Other study ID # NL76165.100.20
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 18, 2022
Est. completion date December 2026

Study information

Verified date February 2024
Source Franciscus Gasthuis
Contact Inger van Duuren
Phone 0031 10 893 61 69
Email proteastudie@franciscus.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first year of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.


Description:

This is a randomised placebo-controlled trial including 500 otherwise healthy moderate-late preterm infants. Participants will receive bacterial lysate (Broncho-Vaxom, 3,5mg) or placebo powder for ten days each month, from 6 weeks after birth until 12 moths of age. Clinical data will be continuously collected by e-Health and 3 (possibly digital) study visits; with optional biological sampling and lung function at baseline, 6 and 12 months. Main study parameters are doctor diagnosed lower RTI and wheezing episodes in the first year of life. Biological sampling will allow investigation of immune maturation, as well as microbiome development in the respiratory tract and gut. Also, biomarkers for risk-group selection and/or treatment success will be examined.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 6 Weeks to 10 Weeks
Eligibility Inclusion Criteria: - Gestational age at delivery between 30+0 and 35+6 weeks - Postnatal age at least 6 weeks at randomization & postmenstrual age at least 37 weeks - Written informed consent by both parents or formal caregivers Exclusion Criteria: - Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder. - Lower RTI before randomization - Dysmaturity and/or weight < 2.5 kg at age of randomization. - Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and/or breastfeeding - Parents unable to speak and read Dutch/English language - Known allergic hypersensitivity to the active ingredients/substance or to any of the excipients.

Study Design


Intervention

Drug:
Broncho-Vaxom
Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.
Other:
Placebo
Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug.

Locations

Country Name City State
Netherlands Franciscus Gasthuis & Vlietland Rotterdam Zuid-Holland

Sponsors (3)

Lead Sponsor Collaborator
Franciscus Gasthuis Leiden University Medical Center, Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (45)

Abreo A, Wu P, Donovan BM, Ding T, Gebretsadik T, Huang X, Stone CA, Turi KN, Hartert TV. Infant Respiratory Syncytial Virus Bronchiolitis and Subsequent Risk of Pneumonia, Otitis Media, and Antibiotic Utilization. Clin Infect Dis. 2020 Jun 24;71(1):211-214. doi: 10.1093/cid/ciz1033. — View Citation

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Blanken MO, Rovers MM, Molenaar JM, Winkler-Seinstra PL, Meijer A, Kimpen JL, Bont L; Dutch RSV Neonatal Network. Respiratory syncytial virus and recurrent wheeze in healthy preterm infants. N Engl J Med. 2013 May 9;368(19):1791-9. doi: 10.1056/NEJMoa1211917. Erratum In: N Engl J Med. 2016 Jun 16;374(24):2406. — View Citation

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Cazzola M, Anapurapu S, Page CP. Polyvalent mechanical bacterial lysate for the prevention of recurrent respiratory infections: a meta-analysis. Pulm Pharmacol Ther. 2012 Feb;25(1):62-8. doi: 10.1016/j.pupt.2011.11.002. Epub 2011 Nov 27. — View Citation

de Boer GM, Zolkiewicz J, Strzelec KP, Ruszczynski M, Hendriks RW, Braunstahl GJ, Feleszko W, Tramper-Stranders GA. Bacterial lysate therapy for the prevention of wheezing episodes and asthma exacerbations: a systematic review and meta-analysis. Eur Respir Rev. 2020 Nov 27;29(158):190175. doi: 10.1183/16000617.0175-2019. Print 2020 Dec 31. — View Citation

de Ruiter K, Jochems SP, Tahapary DL, Stam KA, Konig M, van Unen V, Laban S, Hollt T, Mbow M, Lelieveldt BPF, Koning F, Sartono E, Smit JWA, Supali T, Yazdanbakhsh M. Helminth infections drive heterogeneity in human type 2 and regulatory cells. Sci Transl Med. 2020 Jan 1;12(524):eaaw3703. doi: 10.1126/scitranslmed.aaw3703. — View Citation

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Edwards MO, Kotecha SJ, Lowe J, Richards L, Watkins WJ, Kotecha S. Management of Prematurity-Associated Wheeze and Its Association with Atopy. PLoS One. 2016 May 20;11(5):e0155695. doi: 10.1371/journal.pone.0155695. eCollection 2016. — View Citation

Esposito S, Bianchini S, Bosis S, Tagliabue C, Coro I, Argentiero A, Principi N. A randomized, placebo-controlled, double-blinded, single-centre, phase IV trial to assess the efficacy and safety of OM-85 in children suffering from recurrent respiratory tract infections. J Transl Med. 2019 Aug 23;17(1):284. doi: 10.1186/s12967-019-2040-y. — View Citation

Esposito S, Marchisio P, Prada E, Daleno C, Porretti L, Carsetti R, Bosco A, Ierardi V, Scala A, Principi N. Impact of a mixed bacterial lysate (OM-85 BV) on the immunogenicity, safety and tolerability of inactivated influenza vaccine in children with recurrent respiratory tract infection. Vaccine. 2014 May 7;32(22):2546-52. doi: 10.1016/j.vaccine.2014.03.055. Epub 2014 Mar 26. — View Citation

Galazzo G, van Best N, Bervoets L, Dapaah IO, Savelkoul PH, Hornef MW; GI-MDH consortium; Lau S, Hamelmann E, Penders J. Development of the Microbiota and Associations With Birth Mode, Diet, and Atopic Disorders in a Longitudinal Analysis of Stool Samples, Collected From Infancy Through Early Childhood. Gastroenterology. 2020 May;158(6):1584-1596. doi: 10.1053/j.gastro.2020.01.024. Epub 2020 Jan 18. — View Citation

Haataja P, Korhonen P, Ojala R, Hirvonen M, Korppi M, Gissler M, Luukkaala T, Tammela O. Hospital admissions for lower respiratory tract infections in children born moderately/late preterm. Pediatr Pulmonol. 2018 Feb;53(2):209-217. doi: 10.1002/ppul.23908. Epub 2017 Nov 29. — View Citation

Hill CJ, Lynch DB, Murphy K, Ulaszewska M, Jeffery IB, O'Shea CA, Watkins C, Dempsey E, Mattivi F, Tuohy K, Ross RP, Ryan CA, O' Toole PW, Stanton C. Evolution of gut microbiota composition from birth to 24 weeks in the INFANTMET Cohort. Microbiome. 2017 Jan 17;5(1):4. doi: 10.1186/s40168-016-0213-y. Erratum In: Microbiome. 2017 Feb 14;5(1):21. — View Citation

Jochems SP, de Ruiter K, Solorzano C, Voskamp A, Mitsi E, Nikolaou E, Carniel BF, Pojar S, German EL, Reine J, Soares-Schanoski A, Hill H, Robinson R, Hyder-Wright AD, Weight CM, Durrenberger PF, Heyderman RS, Gordon SB, Smits HH, Urban BC, Rylance J, Collins AM, Wilkie MD, Lazarova L, Leong SC, Yazdanbakhsh M, Ferreira DM. Innate and adaptive nasal mucosal immune responses following experimental human pneumococcal colonization. J Clin Invest. 2019 Jul 30;129(10):4523-4538. doi: 10.1172/JCI128865. Erratum In: J Clin Invest. 2022 Jun 1;132(11): — View Citation

Karaca NE, Gulez N, Aksu G, Azarsiz E, Kutukculer N. Does OM-85 BV prophylaxis trigger autoimmunity in IgA deficient children? Int Immunopharmacol. 2011 Nov;11(11):1747-51. doi: 10.1016/j.intimp.2011.06.009. Epub 2011 Jul 21. — View Citation

Kotecha S, Clemm H, Halvorsen T, Kotecha SJ. Bronchial hyper-responsiveness in preterm-born subjects: A systematic review and meta-analysis. Pediatr Allergy Immunol. 2018 Nov;29(7):715-725. doi: 10.1111/pai.12957. Epub 2018 Sep 5. — View Citation

Lau S, Gerhold K, Zimmermann K, Ockeloen CW, Rossberg S, Wagner P, Sulser C, Bunikowski R, Witt I, Wauer J, Beschorner J, Menke G, Hamelmann E, Wahn U. Oral application of bacterial lysate in infancy decreases the risk of atopic dermatitis in children with 1 atopic parent in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2012 Apr;129(4):1040-7. doi: 10.1016/j.jaci.2012.02.005. — View Citation

Luoto R, Ruuskanen O, Waris M, Kalliomaki M, Salminen S, Isolauri E. Prebiotic and probiotic supplementation prevents rhinovirus infections in preterm infants: a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2014 Feb;133(2):405-13. doi: 10.1016/j.jaci.2013.08.020. Epub 2013 Oct 13. — View Citation

Martinez FD. Childhood Asthma Inception and Progression: Role of Microbial Exposures, Susceptibility to Viruses and Early Allergic Sensitization. Immunol Allergy Clin North Am. 2019 May;39(2):141-150. doi: 10.1016/j.iac.2018.12.001. — View Citation

Matias V, San Feliciano L, Fernandez JE, Lapena S, Garrido E, Ardura J, Soga MJ, Aragon MP, Remesal A, Benito F, Andres J, Centeno F, Marugan V, Bachiller R, Bermejo-Martin JF. Host and environmental factors influencing respiratory secretion of pro-wheezing biomarkers in preterm children. Pediatr Allergy Immunol. 2012 Aug;23(5):441-7. doi: 10.1111/j.1399-3038.2012.01269.x. Epub 2012 May 3. — View Citation

McGreal EP, Hearne K, Spiller OB. Off to a slow start: under-development of the complement system in term newborns is more substantial following premature birth. Immunobiology. 2012 Feb;217(2):176-86. doi: 10.1016/j.imbio.2011.07.027. Epub 2011 Jul 30. — View Citation

Melville JM, Moss TJ. The immune consequences of preterm birth. Front Neurosci. 2013 May 21;7:79. doi: 10.3389/fnins.2013.00079. eCollection 2013. — View Citation

Moschino L, Carraro S, Baraldi E. Early-life origin and prevention of chronic obstructive pulmonary diseases. Pediatr Allergy Immunol. 2020 Feb;31 Suppl 24:16-18. doi: 10.1111/pai.13157. — View Citation

Niele N, van Zwol A, Westerbeek EA, Lafeber HN, van Elburg RM. Effect of non-human neutral and acidic oligosaccharides on allergic and infectious diseases in preterm infants. Eur J Pediatr. 2013 Mar;172(3):317-23. doi: 10.1007/s00431-012-1886-2. Epub 2012 Nov 7. — View Citation

Olin A, Henckel E, Chen Y, Lakshmikanth T, Pou C, Mikes J, Gustafsson A, Bernhardsson AK, Zhang C, Bohlin K, Brodin P. Stereotypic Immune System Development in Newborn Children. Cell. 2018 Aug 23;174(5):1277-1292.e14. doi: 10.1016/j.cell.2018.06.045. — View Citation

Pattaroni C, Watzenboeck ML, Schneidegger S, Kieser S, Wong NC, Bernasconi E, Pernot J, Mercier L, Knapp S, Nicod LP, Marsland CP, Roth-Kleiner M, Marsland BJ. Early-Life Formation of the Microbial and Immunological Environment of the Human Airways. Cell Host Microbe. 2018 Dec 12;24(6):857-865.e4. doi: 10.1016/j.chom.2018.10.019. Epub 2018 Nov 29. — View Citation

Perez-Yarza EG, Moreno-Galdo A, Ramilo O, Rubi T, Escribano A, Torres A, Sardon O, Oliva C, Perez G, Cortell I, Rovira-Amigo S, Pastor-Vivero MD, Perez-Frias J, Velasco V, Torres-Borrego J, Figuerola J, Barrio MI, Garcia-Hernandez G, Mejias A; SAREPREM 3235 investigators. Risk factors for bronchiolitis, recurrent wheezing, and related hospitalization in preterm infants during the first year of life. Pediatr Allergy Immunol. 2015 Dec;26(8):797-804. doi: 10.1111/pai.12414. Epub 2015 Jul 1. — View Citation

Pfefferle PI, Prescott SL, Kopp M. Microbial influence on tolerance and opportunities for intervention with prebiotics/probiotics and bacterial lysates. J Allergy Clin Immunol. 2013 Jun;131(6):1453-63; quiz 1464. doi: 10.1016/j.jaci.2013.03.020. Epub 2013 May 2. — View Citation

Pramana IA, Latzin P, Schlapbach LJ, Hafen G, Kuehni CE, Nelle M, Riedel T, Frey U. Respiratory symptoms in preterm infants: burden of disease in the first year of life. Eur J Med Res. 2011 May 12;16(5):223-30. doi: 10.1186/2047-783x-16-5-223. — View Citation

Razi CH, Harmanci K, Abaci A, Ozdemir O, Hizli S, Renda R, Keskin F. The immunostimulant OM-85 BV prevents wheezing attacks in preschool children. J Allergy Clin Immunol. 2010 Oct;126(4):763-9. doi: 10.1016/j.jaci.2010.07.038. — View Citation

Round JL, Mazmanian SK. Inducible Foxp3+ regulatory T-cell development by a commensal bacterium of the intestinal microbiota. Proc Natl Acad Sci U S A. 2010 Jul 6;107(27):12204-9. doi: 10.1073/pnas.0909122107. Epub 2010 Jun 21. — View Citation

Seppa VP, Paassilta M, Kivisto J, Hult A, Viik J, Gracia-Tabuenca J, Karjalainen J. Reduced expiratory variability index (EVI) is associated with controller medication withdrawal and symptoms in wheezy children aged 1-5 years. Pediatr Allergy Immunol. 2020 Jul;31(5):489-495. doi: 10.1111/pai.13234. Epub 2020 Mar 17. — View Citation

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Sly PD, Galbraith S, Islam Z, Holt B, Troy N, Holt PG. Primary prevention of severe lower respiratory illnesses in at-risk infants using the immunomodulator OM-85. J Allergy Clin Immunol. 2019 Sep;144(3):870-872.e11. doi: 10.1016/j.jaci.2019.05.032. Epub 2019 Jun 8. No abstract available. — View Citation

Stein MM, Hrusch CL, Gozdz J, Igartua C, Pivniouk V, Murray SE, Ledford JG, Marques Dos Santos M, Anderson RL, Metwali N, Neilson JW, Maier RM, Gilbert JA, Holbreich M, Thorne PS, Martinez FD, von Mutius E, Vercelli D, Ober C, Sperling AI. Innate Immunity and Asthma Risk in Amish and Hutterite Farm Children. N Engl J Med. 2016 Aug 4;375(5):411-421. doi: 10.1056/NEJMoa1508749. — View Citation

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Teo SM, Mok D, Pham K, Kusel M, Serralha M, Troy N, Holt BJ, Hales BJ, Walker ML, Hollams E, Bochkov YA, Grindle K, Johnston SL, Gern JE, Sly PD, Holt PG, Holt KE, Inouye M. The infant nasopharyngeal microbiome impacts severity of lower respiratory infection and risk of asthma development. Cell Host Microbe. 2015 May 13;17(5):704-15. doi: 10.1016/j.chom.2015.03.008. Epub 2015 Apr 9. — View Citation

Thorsen J, Rasmussen MA, Waage J, Mortensen M, Brejnrod A, Bonnelykke K, Chawes BL, Brix S, Sorensen SJ, Stokholm J, Bisgaard H. Infant airway microbiota and topical immune perturbations in the origins of childhood asthma. Nat Commun. 2019 Nov 1;10(1):5001. doi: 10.1038/s41467-019-12989-7. — View Citation

Tirone C, Pezza L, Paladini A, Tana M, Aurilia C, Lio A, D'Ippolito S, Tersigni C, Posteraro B, Sanguinetti M, Di Simone N, Vento G. Gut and Lung Microbiota in Preterm Infants: Immunological Modulation and Implication in Neonatal Outcomes. Front Immunol. 2019 Dec 12;10:2910. doi: 10.3389/fimmu.2019.02910. eCollection 2019. — View Citation

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Yin J, Xu B, Zeng X, Shen K. Broncho-Vaxom in pediatric recurrent respiratory tract infections: A systematic review and meta-analysis. Int Immunopharmacol. 2018 Jan;54:198-209. doi: 10.1016/j.intimp.2017.10.032. Epub 2017 Nov 16. — View Citation

* Note: There are 45 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Gut and respiratory microbiome composition Measured from faeces and nasofaryngeal swabs taken at age 6-10 weeks, 6 months and 12 months. In the first year of life.
Other Secretory IgA in saliva Saliva will be collected at age 6-10 weeks, 6 months and 12 months. In the first year of life
Other Immune maturation: immune cells in nasal epithelium Collected by nasal scraping at age 6-10 weeks, 6 months and 12 months. Analysed using masscytometry. In the first year of life
Other Immune maturation: chemokines and cytokines in nasal lining fluid Collected by nasosorption at age 6-10 weeks, 6 months and 12 months. Analysed using Luminex cyto/chemokine assay. In the first year of life
Other Immune maturation: immune cells in bloodsamples Collected by blooddraws at age 6-10 weeks, 6 months and 12 months. Analysed using masscytometry. In the first year of life
Other Serum IgE (total and specific to house dust mite) Measured in blood samples which will be drawn at age 12 months At age 12 months
Other Immune maturation: Single cell transcriptomics Performed on blood drawn at age 12 months At age 12 months
Other Whole blood stimulation essays Performed on blood drawn at age 12 months At age 12 months
Other Biomarkers predictive of high morbidity and/or treatment success From combined microbial and immunological data In the first year of life.
Primary Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life Recorded by frequent questionnaires In the first year of life.
Secondary Time to first lower RTI or wheezing episode Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life. In the first and second year of life.
Secondary Total number of RTI Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life. In the first and second year of life.
Secondary Total number of wheezing episodes Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life. In the first and second year of life.
Secondary Distribution of viruses Viruses present in the nasofarynx during complaints of lower respiratory tract infection or wheezing. Nasofaryngeal swabs will be taken in case of complaints during the first year of life. In the second year of life this will not be done. In the first year of life.
Secondary Medication use (bronchodilators, corticosteroids, antibiotics) Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life. In the first and second year of life.
Secondary Lung function as measured by expiratory variability index (Ventica) Measured at age 6-10 weeks (baseline), 6 months and 12 months in a subset of participants. In the first year of life.
Secondary Quality of life questionnaires Recorded by extensive questionnaires every six months in the first and second year of life. In the first and second year of life.
Secondary (serious) adverse events Will be reported by parents immediately. Respiratory episodes are not regarded as an (S)AE since these episodes comprise primary and secondary outcomes. (S)AE's are only expected in the first year of life because the treatment stops at the age of 12 months. In the first year of life.
Secondary Serum specific IgE (allergen sensitization) at 12 months Total IgE and house dust mite specific IgE At age 12 months
Secondary Infant vaccination titers at 12 months Vaccination titers of haemohilus influenza type B, pneumococci, tetanus At age 12 months
Secondary Costs- and cost-effectiveness Estimated from information from standardized questionnaires In the first and second year of life.
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