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

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

Condition Intervention
Celiac Disease Dietary Supplement: gluten-free, normocaloric diet from 6 to 12 months

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Infant Nutrition and Development of Celiac Disease in Genetically At-risk Babies: a Dietary Intervention Study at Weaning

Resource links provided by NLM:

Further study details as provided by Carlo Catassi, M.D., Università Politecnica delle Marche:

Primary Outcome Measures:
  • prevalence of active CD [ Time Frame: 5 years of age ]

Secondary Outcome Measures:
  • prevalence of CD-related autoantibodies (IgA anti-transglutaminase) [ Time Frame: age 2, 3 and 5 years ]

Enrollment: 703
Study Start Date: September 2004
Study Completion Date: November 2013
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gluten free diet
the intervention in this group is keeping a gluten-free diet from 0 to 12 months
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
No Intervention: Gluten containing diet
infants in this group are started on gluten-containing cereals at 6 months (control group)

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.

Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Newborn in a family where a first-degree relative is already affected with biopsy-proven CD
  Contacts and Locations
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Please refer to this study by its identifier: NCT00639444

Department of Pediatrics, via Corridoni 11
Ancona, Italy, 60123
Sponsors and Collaborators
Università Politecnica delle Marche
Associazione Italiana Celiachia (AIC)
Menarini Group
Principal Investigator: Carlo Catassi, MD Università Politecnica delle Marche
  More Information