Risk of Celiac Disease and Age at Gluten Introduction - Full Text View

Sponsors and Collaborators:	Università Politecnica delle Marche Associazione Italiana Celiachia (AIC) Menarini Group
Information provided by:	Università Politecnica delle Marche
ClinicalTrials.gov Identifier:	NCT00639444

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:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Celiac Disease Children's Health Diets

U.S. FDA Resources

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 ]

Estimated Enrollment:	700
Study Start Date:	September 2004
Estimated Study Completion Date:	December 2012
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Active Comparator Infants in this group maintain a gluten-free diet from 6 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
A: No Intervention 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 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

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

No publications provided

Responsible Party:	Università Politecnica delle Marche ( the president )
Study ID Numbers:	UPM-CE 204332
Study First Received:	March 14, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00639444 History of Changes
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Barley
Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases

Malabsorption Syndromes
Celiac Disease
Intestinal Diseases
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases

Malabsorption Syndromes
Celiac Disease
Intestinal Diseases

ClinicalTrials.gov processed this record on September 10, 2009