Risk of Celiac Disease and Age at Gluten Introduction (CELIPREV)

This study has been completed.
Sponsor:
Collaborators:
Associazione Italiana Celiachia (AIC)
Menarini Group
Information provided by (Responsible Party):
Carlo Catassi, M.D., Università Politecnica delle Marche
ClinicalTrials.gov Identifier:
NCT00639444
First received: March 14, 2008
Last updated: December 9, 2013
Last verified: December 2013

March 14, 2008
December 9, 2013
September 2004
December 2007   (final data collection date for primary outcome measure)
prevalence of active CD [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00639444 on ClinicalTrials.gov Archive Site
prevalence of CD-related autoantibodies (IgA anti-transglutaminase) [ Time Frame: age 2, 3 and 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Risk of Celiac Disease and Age at Gluten Introduction
Infant Nutrition and Development of Celiac Disease in Genetically At-risk Babies: a Dietary Intervention Study at Weaning

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.

We undertook a prospective study to establish the incidence of CD autoimmunity related to the timing of gluten exposure in at-risk infants. Infants at family risk for CD (at least one first-degree relative affected) are enrolled in this prospective, multicentre, intervention study conducted in Italy. Infants are randomly assigned to introduce gluten at either 4-6 or 12 months (groups A and B, respectively) and then enter a follow-up period of 5 years. Duration of breastfeeding and types of formulas, adherence to the dietary plan, amount of gluten administered, and clinical data are collected by phone or direct interview at 4, 7, 9, and 12 months of age. HLA (Human Leucocyte Antigene) status and CD serology (anti-transglutaminase and other autoantibodies) are tested at 15, 24, 36 and 60 months of age.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Celiac Disease
Dietary Supplement: gluten-free, normocaloric diet from 6 to 12 months
Gluten-containing cereals (wheat, rye and barley) will be replaced by gluten-free starchy food (rice, corn, tapioca-based, etc) in a normocaloric diet
Other Name: gluten-free products
  • Active Comparator: Gluten free diet
    the intervention in this group is keeping a gluten-free diet from 0 to 12 months
    Intervention: Dietary Supplement: gluten-free, normocaloric diet from 6 to 12 months
  • No Intervention: Gluten containing diet
    infants in this group are started on gluten-containing cereals at 6 months (control group)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
703
November 2013
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Newborn in a family where a first-degree relative is already affected with biopsy-proven CD
Both
up to 6 Months
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00639444
UPM-CE 204332
No
Carlo Catassi, M.D., Università Politecnica delle Marche
Università Politecnica delle Marche
  • Associazione Italiana Celiachia (AIC)
  • Menarini Group
Principal Investigator: Carlo Catassi, MD Università Politecnica delle Marche
Università Politecnica delle Marche
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP