Condition category
Digestive System
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
15/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.preventcd.com

Contact information

Type

Scientific

Primary contact

Dr M L Mearin

ORCID ID

Contact details

Leiden University Medical Centre
Department Of Pediatrics
P.O. Box 9600
Leiden
2300 RC
Netherlands
M.L.Mearin_Manrique@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR890

Study information

Scientific title

Acronym

PREVENTCD

Study hypothesis

To induce tolerance for gluten in genetically predisposed children for coeliac disease through the introduction of small quantities of gluten during the period of breast-feeding.

Ethics approval

Approval received from the Leiden University Medical Centre (LUMC), Commissie Medische Ethiek on the 1st December 2006 (ref: P06.177). Also the ethical review of the project received a positive opinion from the European Commission; the Commission of the European Communities - Research Directorate - General (Directorate E- Biotechnology, Agriculture and Food research) on the 11th September 2006 (ref: FOOD-CT-2006-36383).

Each partner in the PREVENTCD project has the approval of their local medical ethics board.

Study design

Randomised placebo-controlled parallel-group double-blinded multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Coeliac disease

Intervention

In the family study:
1. The intervention group will get a small amount of gluten (1 gram of wheat flour = 100 mg gliadin) during the period of breastfeeding from the age of four months for eight weeks
2. The control group (placebo) will get milk sugar powder (1 g of lactose) during the period of breast feeding from the age of four months for eight weeks

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

A reduction of 50% of CD among the intervention group at the age of three years will be considered as an effective prevention.

Secondary outcome measures

If the proposed early dietary intervention results in effective prevention of CD:
1. Development of new European guidelines for early nutrition in order to prevent the disease
2. Identification of the influence of early feeding on the development of coeliac disease in relation with immunological and genetical factors

Overall trial start date

01/01/2007

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infant born during the study with a first degree relative (parent or sibling) with coeliac disease (CD)
2. Informed consent for the study

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1000 (including participants from all centres)

Participant exclusion criteria

1. No informed consent
2. Parents-guardians unable to understand the information necessary to give informed consent

Recruitment start date

01/01/2007

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Croatia, Hungary, Israel, Italy, Netherlands, Poland, Spain

Trial participating centre

Leiden University Medical Centre
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (The Netherlands)

Sponsor details

Department of Pediatrics
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/english/start_english.html#http://www.lumc.nl/english/start_english.html

Funders

Funder type

Government

Funder name

European Commission (Belgium)

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25271603

Publication citations

  1. Results

    Vriezinga SL, Auricchio R, Bravi E, Castillejo G, Chmielewska A, Crespo Escobar P, Kolaček S, Koletzko S, Korponay-Szabo IR, Mummert E, Polanco I, Putter H, Ribes-Koninckx C, Shamir R, Szajewska H, Werkstetter K, Greco L, Gyimesi J, Hartman C, Hogen Esch C, Hopman E, Ivarsson A, Koltai T, Koning F, Martinez-Ojinaga E, te Marvelde C, Pavic A, Romanos J, Stoopman E, Villanacci V, Wijmenga C, Troncone R, Mearin ML, Randomized feeding intervention in infants at high risk for celiac disease., N. Engl. J. Med., 2014, 371, 14, 1304-1315, doi: 10.1056/NEJMoa1404172.

Additional files

Editorial Notes