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Completed

NCT Number: NCT00639444

Risk of Celiac Disease and Age at Gluten Introduction

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 day–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatrics, via Corridoni 11

Ancona, 60123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newborn in a family where a first-degree relative is already affected with biopsy-proven CD

Treatment and study plan

gluten-free, normocaloric diet from 6 to 12 months

Dietary Supplement

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 names: gluten-free products

Primary outcomes

  1. prevalence of active CD

    Time frame: 5 years of age

Secondary outcomes

  1. prevalence of CD-related autoantibodies (IgA anti-transglutaminase)

    Time frame: age 2, 3 and 5 years

Sponsors and collaborators

Lead sponsor

Università Politecnica delle Marche

Other

Collaborators

  • Associazione Italiana Celiachia (AIC)
  • Menarini Group

Registry information

Official study title

Infant Nutrition and Development of Celiac Disease in Genetically At-risk Babies: a Dietary Intervention Study at Weaning

Acronym: CELIPREV

Important dates

Study start
2004
Primary completion
2007
Study completion
2013
First posted
Mar 20, 2008
Registry last updated
Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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