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

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.
 
ClinicalTrials.gov Identifier: NCT00639444
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : December 10, 2013
Sponsor:
Collaborators:
Associazione Italiana Celiachia (AIC)
Menarini Group
Information provided by (Responsible Party):
Carlo Catassi, M.D., Università Politecnica delle Marche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Celiac Disease Dietary Supplement: gluten-free, normocaloric diet from 6 to 12 months Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 703 participants
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
Study Start Date : September 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arms and Interventions
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Arm Intervention/treatment
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)


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

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

Eligibility Criteria
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Ages Eligible for Study:   1 Day 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
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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
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Italy
Department of Pediatrics, via Corridoni 11
Ancona, Italy, 60123
Sponsors and Collaborators
Università Politecnica delle Marche
Associazione Italiana Celiachia (AIC)
Menarini Group
Investigators
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Principal Investigator: Carlo Catassi, MD Università Politecnica delle Marche
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Carlo Catassi, M.D., Associate Professor, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT00639444    
Other Study ID Numbers: UPM-CE 204332
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases