Risk Factors for the Development of Celiac Disease in Genetically Predisposed Children (NEOCEL)
31. juli 2019 opdateret af: Renata Auricchio, Federico II University
Natural History, Risk Factors and Predictive Biomarkers for Celiac Disease: a Prospective Multicenter Study.
The study aims to identify risk factors for the development of Celiac Diseases in families with a recognized genetic risk for the presence of a confirmed proband case.
Candidate mother will be recruited before a planned pregnancy or within the first 12 weeks of pregnancy.
Familial and environmental risk factors will be evaluated within the couple of parents.
Pregnancy will be followed up and appropriate biological samples collected.
Delivery will be supervised in order to collect biological samples.
Newborns will be controlled from birth up to the 6th year of age.
Data about clinical events related to health, life attitudes, nutrition will be collected together with biological samples either in the pregnant mother as well as in the infant.
Studieoversigt
Status
Tilmelding efter invitation
Intervention / Behandling
Detaljeret beskrivelse
- CD epidemics: Celiac Disease incidence is increasing at unexpected rates in the last two decades in all gluten-consuming populations.
- Remarkable stratified genetic risk: there is a strong genetic component as the main risk to develop disease, as supported by > 85% concordance in monozygotic twins, but genetics cannot change over decades and does not explain the epidemic which has been observed. The presence of double HLA DQ2 in female subjects does increases the risk of disease above that of a mendelian recessive inheritance. Hence the estimation of environmental factors associated to the genetic risk is quite complex and does need a very strict prospective longitudinal study design, since each factor is likely to produce, if ever, a quite small odds ratio .
- Gene expression in the first year of life: we have observed, in our previous cohort studies, that the expression of at least a small set of CD associated candidate genes is substantially different between the children who eventually develop Cd and those who do not, already a 6 months of age, much before any measurable recognition of the gluten antigen, development of antibodies or any clinical sign (ref 3 Galatola).
- Epigenetic changes in small intestinal tissue: in addition of the previously reported gene expression differences, gene methylation and related expression of CD associated candidate genes have been observed in the epithelium and the lamina propria of Cd patients . In addition, microRNA appear to be differently expressed in patients versus controls.
- Early events in the first-second year of life before diagnosis: our groups and others observed that the occurrenceof acute respiratoryinfections in the first and second year of life, at least 12 months before the onset of disease, was associated to increased odds (> x2) of developing CD. It is most likely that viral infections (as the large majority of URTI in children) play a role in the development of food antigen intolerance leading to CD . A role of non-pathogenic viral infections has been also suggestedin the developmentof intolerance to gluten.
- No influence of breast-feeding or gluten introduction: breast feeding does not prevent the incidence of CD in at risk infants: its most likely effect is to delay the onset of clinical symptoms. Similarly, the time and quantity of gluten introduction is not associated to the actual incidence, but is only associated to delayed time effects.
- Possible implication of microbiome: despite the complexity of estimating differences in the composition of microbiome in the infants, it has been suggested that infants who later develop CD might show a fila composition slightly different from their matched controls.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
400
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Campania
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Naples, Campania, Italien, 80131
- University of Naples Azienda Ospedaliera Universitaria
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Pregnant women from a family with a confirmed CD proband Live newborns from the above mothers
Beskrivelse
Inclusion Criteria:
Pregnant women from a family with a confirmed CD proband
Exclusion Criteria:
Women affected by severe chronic disease and cancer Women not able to attend the schedule of visits
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Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Celiac Disease
Tidsramme: 6 years
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Number of new cases of infants affected by Celiac Disease in relation to genetic (HLA and non-HLA Associated Genes), Epigenetic (DNA Methylation, Gene Expression, Istone Acetylation of candidate gene) and environmental factors (Maternal factors, Nutrition, Infections)
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6 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Analysis of microbiome
Tidsramme: 6 years
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Difference in the microbiome composition of the group of infants who eventually develop Celiac Disease versus those who do not develop the disease. Comparison of Fecal Microbiome of infants at 4, 12 and 24 months subgrouped by outcome. |
6 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2019
Primær færdiggørelse (Forventet)
1. maj 2022
Studieafslutning (Forventet)
30. april 2025
Datoer for studieregistrering
Først indsendt
24. juli 2019
Først indsendt, der opfyldte QC-kriterier
24. juli 2019
Først opslået (Faktiske)
26. juli 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. august 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. juli 2019
Sidst verificeret
1. juli 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NEOCEL2019
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