WheezingPhase 3PROTEANCT05063149
Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.
A Phase 3 study testing Broncho-Vaxom in people with Wheezing and LRTI, run by Franciscus Gasthuis at 1 site in Netherlands.
Trial summary
The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect. Read more about this study
- Who is it for?
- Ages 6 to 10 weeks
- What is being tested?
- Broncho-Vaxom
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Mar 2022to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 6 to 10 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, 3045PM
Gerdien Tramper, MD PhD, +311046117126, proteastudie@franciscus.nl
wetenschapsbureau@franciscus.nl
About this study
Official title: Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.
The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.
Read the detailed description
This is a randomised placebo-controlled trial including 500 otherwise healthy moderate-late preterm infants. Participants will receive bacterial lysate (OM-85/Broncho-Vaxom, 3,5mg) or placebo powder for ten days each month, from 6-10 weeks after birth until 12 months after birth. At 12 months, parents of participants are asked to join in Protea-2. If they do, participants in the treatment arm of year 1 are randomised again over placebo and OM-85 and treated until the age of 24 months. 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.
- Being tested
- Broncho-Vaxom, Placebo
- Keywords
- preterm birth, respiratory tract infections, lung function
- Medical subject headings
- Respiratory Sounds, Premature Birth, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broncho-VaxomDrug
Also called OM-85, Broncho-Vaxom concentrate (Bacterial lysate)
Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.
PlaceboOther
Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug.
| Study group | Role | What they receive |
|---|---|---|
| Broncho-Vaxom treatment | Active comparator | Infants in this arm will be given 3,5mg bacterial lysate (OM-85) 10 days per month from 6 weeks after birth until 12 months of age.
At age 12 months they will be (if informed consent for Protea-2 is provided) randomised over Broncho-Vaxom treatment and placebo again. Receives: Drug: Broncho-Vaxom |
| Placebo | Placebo comparator | Infants in this arm will be given a placebo powder from a capsule that will be indistinguishable from the active study drug. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life
Recorded by frequent questionnaires
Measured: In the first year of life.
Secondary outcomes (11)
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.
Measured: In the first and second year of life.
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.
Measured: In the first and second year of life.
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.
Measured: In the first and second year of life.
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.
Measured: In the first year of life.
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.
Measured: In the first and second year of life.
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.
Measured: In the first year of life.
Quality of life questionnaires
Recorded by extensive questionnaires every six months in the first and second year of life.
Measured: In the first and second year of life.
(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.
Measured: In the first year of life.
Serum specific IgE (allergen sensitization) at 12 months
Total IgE and house dust mite specific IgE
Measured: At age 12 months
Infant vaccination titers at 12 months
Vaccination titers of haemohilus influenza type B, pneumococci, tetanus
Measured: At age 12 months
Costs- and cost-effectiveness
Estimated from information from standardized questionnaires
Measured: In the first and second year of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start18 Mar 2022
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for WheezingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Half of the participants (250) will receive treatment (Broncho-Vaxom) and the other half will receive placebo. Randomization will be stratified for gestational age (moderate (30+0-32+6) vs. late (33+0-35+6) prematurity). In the follow-up study Protea-2, infants from the treatment arm in year 1 will be randomised to receive Broncho-Vaxom or placebo in year 2. Randomisation will stratified for gestational age again, but also for the amount of lower respiratory episodes in year 1 (\<2 vs. \>/=2) Infants from the control arm in year 1 will not receive treatment in year 2.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Maastricht University Medical Center, Erasmus Medical Center
- Responsible party
- Principal investigator, Gerdien Tramper, Franciscus Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063149
- Sponsor's protocol ID
- NL76165.100.20
- Acronym
- PROTEA
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchdata will be shared in data repositories according to the FAIR principle. Clinical data about respiratory health will be shared in the DANS repository. Inlcuding metadata which will ensure reusability. Sequencing data will be shared online in the ENA repository which will provide an unique global identifier. All used bioinformatics pipelines for data analysis will be made accessible on a GitHub account. Immunological data will be shared in NCBI Gene Expression omnibus and ImmPort. Used analysis pipelines for the transcriptomics data will also be tracked and can be shared using a Github account. All data shared will be pneudonymized.
Publications
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.
PubMed 29193814Pramana 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.
PubMed 21719396Vrijlandt EJ, Kerstjens JM, Duiverman EJ, Bos AF, Reijneveld SA. Moderately preterm children have more respiratory problems during their first 5 years of life than children born full term. Am J Respir Crit Care Med. 2013 Jun 1;187(11):1234-40. doi: 10.1164/rccm.201211-2070OC.
PubMed 23525931Perez-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.
PubMed 26031206Edwards 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.
PubMed 27203564Kotecha 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.
PubMed 30014518Moschino 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.
PubMed 32017219Tirone 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.
PubMed 31921169Stewart CJ, Embleton ND, Marrs EC, Smith DP, Nelson A, Abdulkadir B, Skeath T, Petrosino JF, Perry JD, Berrington JE, Cummings SP. Temporal bacterial and metabolic development of the preterm gut reveals specific signatures in health and disease. Microbiome. 2016 Dec 29;4(1):67. doi: 10.1186/s40168-016-0216-8.
PubMed 28034304Arboleya S, Binetti A, Salazar N, Fernandez N, Solis G, Hernandez-Barranco A, Margolles A, de Los Reyes-Gavilan CG, Gueimonde M. Establishment and development of intestinal microbiota in preterm neonates. FEMS Microbiol Ecol. 2012 Mar;79(3):763-72. doi: 10.1111/j.1574-6941.2011.01261.x. Epub 2011 Dec 15.
PubMed 22126419Hill 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.
PubMed 28095889Pattaroni 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.
PubMed 30503510Carraro S, Scheltema N, Bont L, Baraldi E. Early-life origins of chronic respiratory diseases: understanding and promoting healthy ageing. Eur Respir J. 2014 Dec;44(6):1682-96. doi: 10.1183/09031936.00084114. Epub 2014 Oct 16.
PubMed 25323240Martinez 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.
PubMed 30954166Abreo 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.
PubMed 31630167
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.
- ClinicalTrials.gov ID
- NCT05063149
- Acronym / sponsor ID
- PROTEA / NL76165.100.20
- Keywords
- preterm birth, respiratory tract infections, lung function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Franciscus GasthuisUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Maastricht University Medical Center, Erasmus Medical Center
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 Sep 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.
The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.
Detailed description
This is a randomised placebo-controlled trial including 500 otherwise healthy moderate-late preterm infants. Participants will receive bacterial lysate (OM-85/Broncho-Vaxom, 3,5mg) or placebo powder for ten days each month, from 6-10 weeks after birth until 12 months after birth. At 12 months, parents of participants are asked to join in Protea-2. If they do, participants in the treatment arm of year 1 are randomised again over placebo and OM-85 and treated until the age of 24 months. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Half of the participants (250) will receive treatment (Broncho-Vaxom) and the other half will receive placebo. Randomization will be stratified for gestational age (moderate (30+0-32+6) vs. late (33+0-35+6) prematurity). In the follow-up study Protea-2, infants from the treatment arm in year 1 will be randomised to receive Broncho-Vaxom or placebo in year 2. Randomisation will stratified for gestational age again, but also for the amount of lower respiratory episodes in year 1 (<2 vs. >/=2) Infants from the control arm in year 1 will not receive treatment in year 2.
| Arm | Type | Receives |
|---|---|---|
| Broncho-Vaxom treatment | Active comparator | Drug: Broncho-VaxomInfants in this arm will be given 3,5mg bacterial lysate (OM-85) 10 days per month from 6 weeks after birth until 12 months of age. At age 12 months they will be (if informed consent for Protea-2 is provided) randomised over Broncho-Vaxom treatment and placebo again. |
| Placebo | Placebo comparator | Other: PlaceboInfants in this arm will be given a placebo powder from a capsule that will be indistinguishable from the active study drug. |
Who may qualify
- Ages
- 6 to 10 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
- 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.
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 |
|---|---|---|
| Broncho-VaxomAlso: OM-85, Broncho-Vaxom concentrate (Bacterial lysate)Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI. | Drug | Broncho-Vaxom treatment |
| PlaceboPlacebo powder from a capsule will be given, which will be indistinguishable from the active study drug. | Other | Placebo |
Primary outcome
Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life
Time frame: In the first year of life.
Recorded by frequent questionnaires
11 secondary outcomes
Time to first lower RTI or wheezing episode
Time frame: In the first and second year of life.
Total number of RTI
Time frame: In the first and second year of life.
Total number of wheezing episodes
Time frame: In the first and second year of life.
Distribution of viruses
Time frame: In the first year of life.
Medication use (bronchodilators, corticosteroids, antibiotics)
Time frame: In the first and second year of life.
Lung function as measured by expiratory variability index (Ventica)
Time frame: In the first year of life.
Quality of life questionnaires
Time frame: In the first and second year of life.
(serious) adverse events
Time frame: In the first year of life.
Serum specific IgE (allergen sensitization) at 12 months
Time frame: At age 12 months
Infant vaccination titers at 12 months
Time frame: At age 12 months
Costs- and cost-effectiveness
Time frame: In the first and second year of life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 29193814Haataja 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.
- Background: PubMed 21719396Pramana 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.
- Background: PubMed 23525931Vrijlandt EJ, Kerstjens JM, Duiverman EJ, Bos AF, Reijneveld SA. Moderately preterm children have more respiratory problems during their first 5 years of life than children born full term. Am J Respir Crit Care Med. 2013 Jun 1;187(11):1234-40. doi: 10.1164/rccm.201211-2070OC.
- Background: PubMed 26031206Perez-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.
- Background: PubMed 27203564Edwards 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.
- Background: PubMed 30014518Kotecha 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.
- Background: PubMed 32017219Moschino 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.
- Background: PubMed 31921169Tirone 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.
- Background: PubMed 28034304Stewart CJ, Embleton ND, Marrs EC, Smith DP, Nelson A, Abdulkadir B, Skeath T, Petrosino JF, Perry JD, Berrington JE, Cummings SP. Temporal bacterial and metabolic development of the preterm gut reveals specific signatures in health and disease. Microbiome. 2016 Dec 29;4(1):67. doi: 10.1186/s40168-016-0216-8.
- Background: PubMed 22126419Arboleya S, Binetti A, Salazar N, Fernandez N, Solis G, Hernandez-Barranco A, Margolles A, de Los Reyes-Gavilan CG, Gueimonde M. Establishment and development of intestinal microbiota in preterm neonates. FEMS Microbiol Ecol. 2012 Mar;79(3):763-72. doi: 10.1111/j.1574-6941.2011.01261.x. Epub 2011 Dec 15.
- Background: PubMed 28095889Hill 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.
- Background: PubMed 30503510Pattaroni 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.
- Studywebsite for participants and health care personnelLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Researchdata will be shared in data repositories according to the FAIR principle. Clinical data about respiratory health will be shared in the DANS repository. Inlcuding metadata which will ensure reusability. Sequencing data will be shared online in the ENA repository which will provide an unique global identifier. All used bioinformatics pipelines for data analysis will be made accessible on a GitHub account. Immunological data will be shared in NCBI Gene Expression omnibus and ImmPort. Used analysis pipelines for the transcriptomics data will also be tracked and can be shared using a Github account. All data shared will be pneudonymized.
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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.
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 Broncho-Vaxom in people with Wheezing and LRTI, run by Franciscus Gasthuis at 1 site in Netherlands.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerdien Tramper, MD PhD (0031 10 4617126, proteastudie@franciscus.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life (time frame: In the first year of life.). 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 NCT05063149, which also lists 45 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 25 Sep 2026.