Ochrona wcześniaków przed infekcjami dróg oddechowych i świszczącym oddechem za pomocą lizatów bakteryjnych. (PROTEA)
23 września 2026 zaktualizowane przez: Gerdien Tramper, Franciscus Gasthuis
Ochrona późnych i umiarkowanych wcześniaków przed infekcjami dróg oddechowych i świszczącym oddechem w pierwszym roku życia za pomocą lizatów bakteryjnych.
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.
Przegląd badań
Status
Status
Rekrutacyjny
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Typ studiów
Interwencyjne
Zapisy (Szacowany)
Zapisy
500
Faza
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Gerdien Tramper, MD PhD
- Numer telefonu: 0031 10 4617126
- E-mail: proteastudie@franciscus.nl
Lokalizacje studiów
-
-
South Holland
-
Rotterdam, South Holland, Holandia, 3045PM
- Rekrutacyjny
- Franciscus Gasthuis & Vlietland
-
Kontakt:
- Gerdien Tramper, MD PhD
- Numer telefonu: +311046117126
- E-mail: proteastudie@franciscus.nl
-
Kontakt:
- E-mail: wetenschapsbureau@franciscus.nl
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
1 miesiąc do 2 miesiące (Dziecko)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Liczba ramion
2
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Aktywny 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.
Inne nazwy:
|
|
Komparator 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life
Ramy czasowe: In the first year of life.
|
Recorded by frequent questionnaires |
In the first year of life.
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Time to first lower RTI or wheezing episode
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: At age 12 months
|
Total IgE and house dust mite specific IgE |
At age 12 months
|
|
Infant vaccination titers at 12 months
Ramy czasowe: At age 12 months
|
Vaccination titers of haemohilus influenza type B, pneumococci, tetanus |
At age 12 months
|
|
Costs- and cost-effectiveness
Ramy czasowe: In the first and second year of life.
|
Estimated from information from standardized questionnaires |
In the first and second year of life.
|
Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Gut and respiratory microbiome composition
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: At age 12 months
|
Performed on blood drawn at age 12 months |
At age 12 months
|
|
Whole blood stimulation essays
Ramy czasowe: 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
Ramy czasowe: In the first year of life.
|
From combined microbial and immunological data |
In the first year of life.
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
- Vrijlandt 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Stewart 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.
- Arboleya 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.
- 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.
- Carraro 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Sjogren YM, Tomicic S, Lundberg A, Bottcher MF, Bjorksten B, Sverremark-Ekstrom E, Jenmalm MC. Influence of early gut microbiota on the maturation of childhood mucosal and systemic immune responses. Clin Exp Allergy. 2009 Dec;39(12):1842-51. doi: 10.1111/j.1365-2222.2009.03326.x. Epub 2009 Sep 3.
- Dzidic M, Abrahamsson TR, Artacho A, Bjorksten B, Collado MC, Mira A, Jenmalm MC. Aberrant IgA responses to the gut microbiota during infancy precede asthma and allergy development. J Allergy Clin Immunol. 2017 Mar;139(3):1017-1025.e14. doi: 10.1016/j.jaci.2016.06.047. Epub 2016 Aug 13.
- 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.
- 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.
- 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.
- Vissing NH, Larsen JM, Rasmussen MA, Chawes BL, Thysen AH, Bonnelykke K, Brix S, Bisgaard H. Susceptibility to Lower Respiratory Infections in Childhood is Associated with Perturbation of the Cytokine Response to Pathogenic Airway Bacteria. Pediatr Infect Dis J. 2016 May;35(5):561-6. doi: 10.1097/INF.0000000000001092.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Beyrend G, Stam K, Hollt T, Ossendorp F, Arens R. Cytofast: A workflow for visual and quantitative analysis of flow and mass cytometry data to discover immune signatures and correlations. Comput Struct Biotechnol J. 2018 Oct 24;16:435-442. doi: 10.1016/j.csbj.2018.10.004. eCollection 2018.
- Badurdeen S, Marshall A, Daish H, Hatherill M, Berkley JA. Safety and Immunogenicity of Early Bacillus Calmette-Guerin Vaccination in Infants Who Are Preterm and/or Have Low Birth Weights: A Systematic Review and Meta-analysis. JAMA Pediatr. 2019 Jan 1;173(1):75-85. doi: 10.1001/jamapediatrics.2018.4038.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
18 marca 2022
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
1 grudnia 2029
Ukończenie studiów (Szacowany)
Ukończenie studiów
1 grudnia 2030
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
24 sierpnia 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
20 września 2021
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
30 września 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
25 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
23 września 2026
Ostatnia weryfikacja
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby układu moczowo-płciowego kobiet i powikłania ciąży
- Poród położniczy, przedwczesny
- Powikłania porodu położniczego
- Powikłania ciąży
- Infekcje
- Choroby Układu Oddechowego
- Oznaki i objawy, układ oddechowy
- Stany patologiczne, oznaki i objawy
- Objawy i symptomy
- Przedwczesny poród
- Infekcje dróg oddechowych
- Dźwięki oddechowe
- Broncho-Vaxom
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- NL76165.100.20
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu 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.
Ramy czasowe udostępniania IPD
Data will come available after publication of the data in articles by initating researchers.
Kryteria dostępu do udostępniania 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .