Skydda för tidigt födda barn från luftvägsinfektioner och väsande andning genom att använda bakteriella lysater. (PROTEA)
Skydda sent-måttliga för tidigt födda barn från luftvägsinfektioner och väsande andning under deras första levnadsår genom att använda bakteriella lysater.
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Gerdien Tramper, MD PhD
- Telefonnummer: 0031 10 4617126
- E-post: proteastudie@franciscus.nl
Studieorter
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South Holland
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Rotterdam, South Holland, Nederländerna, 3045PM
- Rekrytering
- Franciscus Gasthuis & Vlietland
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Kontakt:
- Gerdien Tramper, MD PhD
- Telefonnummer: +311046117126
- E-post: proteastudie@franciscus.nl
-
Kontakt:
- E-post: wetenschapsbureau@franciscus.nl
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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.
Andra namn:
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Placebo-jämförare: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life
Tidsram: In the first year of life.
|
Recorded by frequent questionnaires |
In the first year of life.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to first lower RTI or wheezing episode
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: At age 12 months
|
Total IgE and house dust mite specific IgE |
At age 12 months
|
|
Infant vaccination titers at 12 months
Tidsram: At age 12 months
|
Vaccination titers of haemohilus influenza type B, pneumococci, tetanus |
At age 12 months
|
|
Costs- and cost-effectiveness
Tidsram: In the first and second year of life.
|
Estimated from information from standardized questionnaires |
In the first and second year of life.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gut and respiratory microbiome composition
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: At age 12 months
|
Performed on blood drawn at age 12 months |
At age 12 months
|
|
Whole blood stimulation essays
Tidsram: 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
Tidsram: In the first year of life.
|
From combined microbial and immunological data |
In the first year of life.
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
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Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Obstetrisk förlossning, för tidigt
- Obstetriska förlossningskomplikationer
- Graviditetskomplikationer
- Infektioner
- Luftvägssjukdomar
- Tecken och symtom, andningsvägar
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- För tidig födsel
- Luftvägsinfektioner
- Andningsljud
- Broncho-Vaxom
Andra studie-ID-nummer
- NL76165.100.20
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
Data will come available after publication of the data in articles by initating researchers.
Kriterier för IPD Sharing Access
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.
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Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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