Back to resultsRisk of Celiac Disease and Age at Gluten Introduction (CELIPREV)
Primary Purpose
Celiac Disease
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
gluten-free, normocaloric diet from 6 to 12 months
Sponsored by
About this trial
This is an interventional prevention trial for Celiac Disease
Eligibility Criteria
Inclusion Criteria:
- Newborn in a family where a first-degree relative is already affected with biopsy-proven CD
Sites / Locations
- Department of Pediatrics, via Corridoni 11
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Gluten free diet
Gluten containing diet
Arm Description
the intervention in this group is keeping a gluten-free diet from 0 to 12 months
infants in this group are started on gluten-containing cereals at 6 months (control group)
Outcomes
Primary Outcome Measures
prevalence of active CD
Secondary Outcome Measures
prevalence of CD-related autoantibodies (IgA anti-transglutaminase)
Full Information
NCT ID
NCT00639444
First Posted
March 14, 2008
Last Updated
December 9, 2013
Sponsor
Università Politecnica delle Marche
Collaborators
Associazione Italiana Celiachia (AIC), Menarini Group
1. Study Identification
Unique Protocol Identification Number
NCT00639444
Brief Title
Risk of Celiac Disease and Age at Gluten Introduction
Acronym
CELIPREV
Official Title
Infant Nutrition and Development of Celiac Disease in Genetically At-risk Babies: a Dietary Intervention Study at Weaning
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Politecnica delle Marche
Collaborators
Associazione Italiana Celiachia (AIC), Menarini Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
703 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gluten free diet
Arm Type
Active Comparator
Arm Description
the intervention in this group is keeping a gluten-free diet from 0 to 12 months
Arm Title
Gluten containing diet
Arm Type
No Intervention
Arm Description
infants in this group are started on gluten-containing cereals at 6 months (control group)
Intervention Type
Dietary Supplement
Intervention Name(s)
gluten-free, normocaloric diet from 6 to 12 months
Other Intervention Name(s)
gluten-free products
Intervention Description
Gluten-containing cereals (wheat, rye and barley) will be replaced by gluten-free starchy food (rice, corn, tapioca-based, etc) in a normocaloric diet
Primary Outcome Measure Information:
Title
prevalence of active CD
Time Frame
5 years of age
Secondary Outcome Measure Information:
Title
prevalence of CD-related autoantibodies (IgA anti-transglutaminase)
Time Frame
age 2, 3 and 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newborn in a family where a first-degree relative is already affected with biopsy-proven CD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Catassi, MD
Organizational Affiliation
Università Politecnica delle Marche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, via Corridoni 11
City
Ancona
ZIP/Postal Code
60123
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22704250
Citation
Lionetti E, Castellaneta S, Pulvirenti A, Tonutti E, Francavilla R, Fasano A, Catassi C; Italian Working Group of Weaning and Celiac Disease Risk. Prevalence and natural history of potential celiac disease in at-family-risk infants prospectively investigated from birth. J Pediatr. 2012 Nov;161(5):908-14. doi: 10.1016/j.jpeds.2012.05.008. Epub 2012 Jun 15.
Results Reference
background
PubMed Identifier
25271602
Citation
Lionetti E, Castellaneta S, Francavilla R, Pulvirenti A, Tonutti E, Amarri S, Barbato M, Barbera C, Barera G, Bellantoni A, Castellano E, Guariso G, Limongelli MG, Pellegrino S, Polloni C, Ughi C, Zuin G, Fasano A, Catassi C; SIGENP (Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition) Working Group on Weaning and CD Risk. Introduction of gluten, HLA status, and the risk of celiac disease in children. N Engl J Med. 2014 Oct 2;371(14):1295-303. doi: 10.1056/NEJMoa1400697.
Results Reference
derived
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Risk of Celiac Disease and Age at Gluten Introduction
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