Risk of Celiac Disease and Age at Gluten Introduction

Not Applicable

Completed

• Conditions: Celiac Disease
• Interventions: Dietary Supplement: gluten-free, normocaloric diet from 6 to 12 months

• Registration Number: NCT00639444
• Lead Sponsor: Università Politecnica delle Marche

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.

Detailed 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.

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2007-12
• Study First Submitted: 2008-03-14
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-20
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 703

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gluten free diet	gluten-free, normocaloric diet from 6 to 12 months	the intervention in this group is keeping a gluten-free diet from 0 to 12 months

Primary Outcome Measures

Name	Time	Method
prevalence of active CD	5 years of age

Secondary Outcome Measures

Name	Time	Method
prevalence of CD-related autoantibodies (IgA anti-transglutaminase)	age 2, 3 and 5 years

Trial Locations

Locations (1)

Department of Pediatrics, via Corridoni 11; 🇮🇹 Ancona, Italy