Risk of Celiac Disease and Age at Gluten Introduction

Celiac Disease Clinical Trial

— CELIPREV  

Official title:

Infant Nutrition and Development of Celiac Disease in Genetically At-risk Babies: a Dietary Intervention Study at Weaning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639444
• Other study ID #: UPM-CE 204332
• Status: Completed
• Phase: N/A
• First received: March 14, 2008
• Last updated: December 9, 2013
• Start date: September 2004
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Università Politecnica delle Marche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 703
• Est. completion date: November 2013
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Newborn in a family where a first-degree relative is already affected with biopsy-proven CD

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Celiac Disease

Intervention

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

Locations

Country	Name	City	State
Italy	Department of Pediatrics, via Corridoni 11	Ancona

Sponsors (3)

Lead Sponsor	Collaborator
Università Politecnica delle Marche	Associazione Italiana Celiachia (AIC), Menarini Group

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of active CD		5 years of age	No
Secondary	prevalence of CD-related autoantibodies (IgA anti-transglutaminase)		age 2, 3 and 5 years	No