Risk of Celiac Disease and Age at Gluten Introduction
CELIPREV
Infant Nutrition and Development of Celiac Disease in Genetically At-risk Babies: a Dietary Intervention Study at Weaning
1 other identifier
interventional
703
1 country
1
Brief Summary
The purpose of this study is to determine whether age at introduction of gluten-containing cereals (e.g. wheat) plays a role in influencing the risk of celiac disease (CD) development in infants with a first-degree relative affected by CD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 14, 2008
CompletedFirst Posted
Study publicly available on registry
March 20, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedDecember 10, 2013
December 1, 2013
3.2 years
March 14, 2008
December 9, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
prevalence of active CD
5 years of age
Secondary Outcomes (1)
prevalence of CD-related autoantibodies (IgA anti-transglutaminase)
age 2, 3 and 5 years
Study Arms (2)
Gluten free diet
ACTIVE COMPARATORthe intervention in this group is keeping a gluten-free diet from 0 to 12 months
Gluten containing diet
NO INTERVENTIONinfants in this group are started on gluten-containing cereals at 6 months (control group)
Interventions
Gluten-containing cereals (wheat, rye and barley) will be replaced by gluten-free starchy food (rice, corn, tapioca-based, etc) in a normocaloric diet
Eligibility Criteria
You may qualify if:
- Newborn in a family where a first-degree relative is already affected with biopsy-proven CD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Università Politecnica delle Marchelead
- Associazione Italiana Celiachia (AIC)collaborator
- Menarini Groupcollaborator
Study Sites (1)
Department of Pediatrics, via Corridoni 11
Ancona, 60123, Italy
Related Publications (2)
Lionetti E, Castellaneta S, Pulvirenti A, Tonutti E, Francavilla R, Fasano A, Catassi C; Italian Working Group of Weaning and Celiac Disease Risk. Prevalence and natural history of potential celiac disease in at-family-risk infants prospectively investigated from birth. J Pediatr. 2012 Nov;161(5):908-14. doi: 10.1016/j.jpeds.2012.05.008. Epub 2012 Jun 15.
PMID: 22704250BACKGROUNDLionetti E, Castellaneta S, Francavilla R, Pulvirenti A, Tonutti E, Amarri S, Barbato M, Barbera C, Barera G, Bellantoni A, Castellano E, Guariso G, Limongelli MG, Pellegrino S, Polloni C, Ughi C, Zuin G, Fasano A, Catassi C; SIGENP (Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition) Working Group on Weaning and CD Risk. Introduction of gluten, HLA status, and the risk of celiac disease in children. N Engl J Med. 2014 Oct 2;371(14):1295-303. doi: 10.1056/NEJMoa1400697.
PMID: 25271602DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlo Catassi, MD
Università Politecnica delle Marche
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 14, 2008
First Posted
March 20, 2008
Study Start
September 1, 2004
Primary Completion
December 1, 2007
Study Completion
November 1, 2013
Last Updated
December 10, 2013
Record last verified: 2013-12