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Sponsors and Collaborators: |
Università Politecnica delle Marche Associazione Italiana Celiachia (AIC) Menarini Group |
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Information provided by: | Università Politecnica delle Marche |
ClinicalTrials.gov Identifier: | NCT00639444 |
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 |
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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 |
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 |
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B: Active Comparator
Infants in this group maintain a gluten-free diet from 6 to 12 months
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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
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A: No Intervention
infants in this group are started on gluten-containing cereals at 6 months (control group)
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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.
Ages Eligible for Study: | up to 6 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Italy | |
Department of Pediatrics, via Corridoni 11 | |
Ancona, Italy, 60123 |
Principal Investigator: | Carlo Catassi, MD | Università Politecnica delle Marche |
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 |
Health Authority: | Italy: Ministry of Health |
Metabolic Diseases Digestive System Diseases Gastrointestinal Diseases Malabsorption Syndromes |
Celiac Disease Metabolic disorder Intestinal Diseases |