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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Università Politecnica delle Marche:

Primary Outcome Measures:
  • prevalence of active CD [ Time Frame: 5 years of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • prevalence of CD-related autoantibodies (IgA anti-transglutaminase) [ Time Frame: age 2, 3 and 5 years ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00639444

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

Publications:
Responsible Party: Carlo Catassi, M.D., Associate Professor, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT00639444     History of Changes
Other Study ID Numbers: UPM-CE 204332
Study First Received: March 14, 2008
Last Updated: December 9, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on July 20, 2014