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

Università Politecnica delle Marche

Status: Completed

Conditions: Celiac Disease

Treatments: Dietary Supplement: gluten-free, normocaloric diet from 6 to 12 months

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00639444

UPM-CE 204332

Details and patient eligibility

About

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.

Full 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.

Enrollment: 703 patients

Sex: All

Ages: 1 day to 6 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

703 participants in 2 patient groups

Gluten free diet

Active Comparator group

Description:

the intervention in this group is keeping a gluten-free diet from 0 to 12 months

Treatment:

Dietary Supplement: gluten-free, normocaloric diet from 6 to 12 months

Gluten containing diet

No Intervention group

Description:

infants in this group are started on gluten-containing cereals at 6 months (control group)