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NCT04034303: NEOCEL
Risk Factors for the Development of Celiac Disease in Genetically Predisposed Children
trial testing analysis of genetic and epigenetic risk factors in Prevention of Clinical Symptoms in Celiac Disease in 400 participants. Status unknown.
1 May 2022
Quick facts
| Lead sponsor | Federico II University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 1 May 2019 |
| Primary completion | 1 May 2022 |
| Estimated completion | 30 April 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- analysis of genetic and epigenetic risk factors
Conditions studied
- Prevention of Clinical Symptoms in Celiac Disease — all drugs for Prevention of Clinical Symptoms in Celiac Disease →
Sponsor
Federico II University
Who can join
Adults 18 to 45, any sex, with Prevention of Clinical Symptoms in Celiac Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04034303
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04034303 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federico II University
- Last refreshed: 2 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04034303.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing