Influence of the dietary history in the PREVENTion of Coeliac Disease: possibilities of induction of tolerance for gluten in genetic predisposed children

ISRCTN	ISRCTN74582487
DOI	https://doi.org/10.1186/ISRCTN74582487
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	NTR890
Sponsor	Leiden University Medical Centre (LUMC) (The Netherlands)
Funder	European Commission (Belgium)

Submission date: 26/02/2007
Registration date: 26/02/2007
Last edited: 27/05/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M L Mearin
Scientific

Leiden University Medical Centre
Department Of Pediatrics
P.O. Box 9600
Leiden
2300 RC
Netherlands

Email	M.L.Mearin_Manrique@lumc.nl

Study information

Primary study design	Interventional
Study design	Randomised placebo-controlled parallel-group double-blinded multicentre trial
Secondary study design	Randomised controlled trial
Scientific title	Randomized Feeding Intervention in Infants at High Risk for Celiac Disease
Study acronym	PREVENTCD
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	A reduction of 50% of CD among the intervention group at the age of three years will be considered as an effective prevention.
Key secondary outcome measure(s)	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
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	1000
Total final enrolment	944
Key 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
Key exclusion criteria	1. No informed consent 2. Parents-guardians unable to understand the information necessary to give informed consent
Date of first enrolment	26/05/2007
Date of final enrolment	10/09/2013

Locations

Countries of recruitment

Croatia
Hungary
Israel
Italy
Netherlands
Poland
Spain

Study participating centre

Leiden University Medical Centre

Leiden
2300 RC
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/10/2014		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/05/2021: The following changes were made to the trial record:
1. The scientific title was added.
2. The total final enrolment was added.
3. The recruitment start date was changed from 01/01/2007 to 26/05/2007.
4. The recruitment end date was changed from 31/12/2011 to 10/09/2013.