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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00639444
First Posted: March 20, 2008
Last Update Posted: December 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Associazione Italiana Celiachia (AIC)
Menarini Group
Information provided by (Responsible Party):
Carlo Catassi, M.D., Università Politecnica delle Marche
  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
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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