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Risk of Celiac Disease and Age at Gluten Introduction

NCT ID: NCT00639444

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

703 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2013-11-30

Brief Summary

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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

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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 (Human Leucocyte Antigene) status and CD serology (anti-transglutaminase and other autoantibodies) are tested at 15, 24, 36 and 60 months of age.

Conditions

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Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Gluten free diet

the intervention in this group is keeping a gluten-free diet from 0 to 12 months

Group Type ACTIVE_COMPARATOR

gluten-free, normocaloric diet from 6 to 12 months

Intervention Type 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

Gluten containing diet

infants in this group are started on gluten-containing cereals at 6 months (control group)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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gluten-free products

Eligibility Criteria

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Inclusion Criteria

* Newborn in a family where a first-degree relative is already affected with biopsy-proven CD
Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Associazione Italiana Celiachia (AIC)

OTHER

Sponsor Role collaborator

Menarini Group

INDUSTRY

Sponsor Role collaborator

Università Politecnica delle Marche

OTHER

Sponsor Role lead

Responsible Party

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Carlo Catassi, M.D.

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlo Catassi, MD

Role: PRINCIPAL_INVESTIGATOR

Università Politecnica delle Marche

Locations

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Department of Pediatrics, via Corridoni 11

Ancona, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 22704250 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25271602 (View on PubMed)

Other Identifiers

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UPM-CE 204332

Identifier Type: -

Identifier Source: org_study_id