Protéger les prématurés des infections des voies respiratoires et de la respiration sifflante en utilisant des lysats bactériens. (PROTEA)
23 septembre 2026 mis à jour par: Gerdien Tramper, Franciscus Gasthuis
Protéger les nourrissons prématurés tardifs à modérés contre les infections des voies respiratoires et la respiration sifflante au cours de leur première année de vie en utilisant des lysats bactériens.
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.
Aperçu de l'étude
Statut
Statut
Recrutement
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Description détaillée
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.
Type d'étude
Type d'étude
Interventionnel
Inscription (Estimé)
Inscription
500
Phase
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
Coordonnées de l'étude
- Nom: Gerdien Tramper, MD PhD
- Numéro de téléphone: 0031 10 4617126
- E-mail: proteastudie@franciscus.nl
Lieux d'étude
-
-
South Holland
-
Rotterdam, South Holland, Pays-Bas, 3045PM
- Recrutement
- Franciscus Gasthuis & Vlietland
-
Contact:
- Gerdien Tramper, MD PhD
- Numéro de téléphone: +311046117126
- E-mail: proteastudie@franciscus.nl
-
Contact:
- E-mail: wetenschapsbureau@franciscus.nl
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
1 mois à 2 mois (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Nombre de bras
2
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
|
Comparateur actif: Broncho-Vaxom treatment
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. |
Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.
Autres noms:
|
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Comparateur placebo: Placebo
Infants in this arm will be given a placebo powder from a capsule that will be indistinguishable from the active study drug. |
Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug. |
Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life
Délai: In the first year of life.
|
Recorded by frequent questionnaires |
In the first year of life.
|
Mesures de résultats secondaires
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to first lower RTI or wheezing episode
Délai: In the first and second year of life.
|
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.
|
|
Total number of RTI
Délai: In the first and second year of life.
|
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.
|
|
Total number of wheezing episodes
Délai: In the first and second year of life.
|
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.
|
|
Distribution of viruses
Délai: In the first year of life.
|
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.
|
|
Medication use (bronchodilators, corticosteroids, antibiotics)
Délai: In the first and second year of life.
|
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.
|
|
Lung function as measured by expiratory variability index (Ventica)
Délai: In the first year of life.
|
Measured at age 6-10 weeks (baseline), 6 months and 12 months in a subset of participants. |
In the first year of life.
|
|
Quality of life questionnaires
Délai: In the first and second year of life.
|
Recorded by extensive questionnaires every six months in the first and second year of life. |
In the first and second year of life.
|
|
(serious) adverse events
Délai: In the first year of life.
|
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.
|
|
Serum specific IgE (allergen sensitization) at 12 months
Délai: At age 12 months
|
Total IgE and house dust mite specific IgE |
At age 12 months
|
|
Infant vaccination titers at 12 months
Délai: At age 12 months
|
Vaccination titers of haemohilus influenza type B, pneumococci, tetanus |
At age 12 months
|
|
Costs- and cost-effectiveness
Délai: In the first and second year of life.
|
Estimated from information from standardized questionnaires |
In the first and second year of life.
|
Autres mesures de résultats
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Gut and respiratory microbiome composition
Délai: In the first year of life.
|
Measured from faeces and nasofaryngeal swabs taken at age 6-10 weeks, 6 months and 12 months. |
In the first year of life.
|
|
Secretory IgA in saliva or nasal lining fluid
Délai: In the first year of life
|
Saliva will be collected at age 6-10 weeks, 6 months and 12 months. |
In the first year of life
|
|
Immune maturation: immune cells in nasal epithelium
Délai: In the first year of life
|
Collected by nasal scraping at age 6-10 weeks, 6 months and 12 months. Analysed using masscytometry. |
In the first year of life
|
|
Immune maturation: chemokines and cytokines in nasal lining fluid
Délai: In the first year of life
|
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
|
|
Immune maturation: immune cells in bloodsamples
Délai: In the first year of life
|
Collected by blooddraws at age 6-10 weeks, 6 months and 12 months. Analysed using masscytometry. |
In the first year of life
|
|
Serum IgE (total and specific to house dust mite)
Délai: At age 12 months
|
Measured in blood samples which will be drawn at age 12 months |
At age 12 months
|
|
Immune maturation: Single cell transcriptomics
Délai: At age 12 months
|
Performed on blood drawn at age 12 months |
At age 12 months
|
|
Whole blood stimulation essays
Délai: At age 12 months
|
Performed on blood drawn at age 12 months |
At age 12 months
|
|
Biomarkers predictive of high morbidity and/or treatment success
Délai: In the first year of life.
|
From combined microbial and immunological data |
In the first year of life.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Parrainer
Collaborateurs
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
Début de l'étude
18 mars 2022
Achèvement primaire (Estimé)
Achèvement primaire
1 décembre 2029
Achèvement de l'étude (Estimé)
Achèvement de l'étude
1 décembre 2030
Dates d'inscription aux études
Première soumission
Première soumission
24 août 2021
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
20 septembre 2021
Première publication (Réel)
Première publication
30 septembre 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
25 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 septembre 2026
Dernière vérification
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies urogénitales féminines et complications de la grossesse
- Travail obstétrique, prématuré
- Complications du travail obstétrical
- Complications de grossesse
- Infections
- Maladies des voies respiratoires
- Signes et symptômes respiratoires
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Naissance prématurée
- Infections des voies respiratoires
- Sons respiratoires
- Broncho-Vaxom
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- NL76165.100.20
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
Data will come available after publication of the data in articles by initating researchers.
Critères d'accès au partage IPD
Data will be available under restricted access. A request for data sharing will include at least the reason for request (for what will the receiver use the data?) and agreements about authorship.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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