|- candidate number||2450|
|- NTR Number||NTR890|
|- Date ISRCTN created||26-feb-2007|
|- date ISRCTN requested||21-feb-2007|
|- Date Registered NTR||8-feb-2007|
|- Secondary IDs||N/A |
|- Public Title||Influence of the dietary history in the prevention of coeliac disease: possibilities of induction of tolerance for gluten in genetic predisposed children.|
|- Scientific Title||Influence of the dietary history in the prevention of coeliac disease: possibilities of induction of tolerance for gluten in genetic predisposed children.|
|- 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.|
|- Healt Condition(s) or Problem(s) studied||Coeliac disease , Breastfeeding , Early feeding , Genetic predisposition , Human leukocyte antigen (HLA), Food intervention |
|- Inclusion criteria||1.Infant born during the study with a first degree relative (parent or sibling) with CD;
2.Informed consent for the study.
|- Exclusion criteria||1. No informed consent;
2. Parents-guardians unable to understand the information necessary to give informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jan-2007|
|- planned closingdate||31-dec-2010|
|- Target number of participants||1000|
|- Interventions||In the family study:
1. The ‘intervention group’ will get a small amount of gluten (1 gram of wheat flour= 100mg gliadin) during the period of breastfeeding from the age of 4 months for 8 weeks.
2. The ‘control group' (placebo) will get milk sugar powder (1gram of lactose) during the period of breastfeeding from the age of 4 months for 8 weeks.|
|- Primary outcome||A reduction of 50% of CD among the intervention group at the age of 3 years will be considered as an effective prevention.
|- Secondary outcome||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.
|- Trial web site||http://www.preventcd.com|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. M.L. Mearin|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M.L. Mearin|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Pediatrics, University of Naples, Federico II, Dept. of Pediatrics, The Medical University of Warsaw, Dept. of Paediatric Gastroenterology & Nutrition, Heim Pal Children's Hospital, Coeliakia Centrum, Hospital Universitari de Sant Joan de Reus, Dept. of Paediatrics, Hospital Univer.Infantil "La Paz" , Meyer Children' Hospital of Haifa, The Pediatric Gastroenterology and Nutrition Unit, Servico de Gastroenterologia Hospital Infantil, Universitario “La Fe”, Children's Hospital Zagreb, Center for Paediatric Gastroenterology & Nutrition|
(Source(s) of Monetary or Material Support)
|- Publications||Statistical Analysis Plan, 74582487, August 1st, 2013, Prof.dr.H. Putter, Dr. M. L. Mearin, Sabine Vriezinga|
|- Brief summary||Title of the study:
Influence of the dietary history in the prevention of coeliac disease : possibilities of induction of tolerance for gluten in genetically predisposed children.
Background of the study:
Coeliac disease (CD) is a chronic disorder caused by hypersensitivity to some of the most common proteins (gluten) in the diet of the European population. CD affects as much as 1% of the Europeans (2.5 million people) and is the most common food intolerance in Europe. If recognised, CD patients have only limited access to safe foods and there is not causal therapy available. The proposed study is a multicenter European project PREVENTCD, founded by the European Commission FP-6-2005-FOOD-4B; Proposal/Contract no.: 036383.
The general objective of PREVENTCD is to significantly reduce the number of people suffering from CD in Europe, by developing primary prevention strategies for CD.
The hypothesis of the study is that it is possible to induce tolerance for gluten in genetically predisposed children through the introduction of small quantities of gluten during the period of breast-feeding.
Objective of the study:
1. Development of a prevention strategy for CD in children from high risk families for the disease by induction of oral tolerance to gluten;
2. Identification of the immunological mechanisms involved in initiating the aberrant response to gluten introduction in the diet of infants genetically predisposed to CD;
3. Identification of the factors in the early dietary history involved in the aberrant response to gluten in children;
European, multicenter, double blind, prospective, randomised food intervention study
1000 infants born from families with one parent or sibling with diagnosed CD.
The children bearing HLA-DQ2 and/or DQ8 will be blindly randomised to either a group for "tolerance induction for gluten" or to a "control" group. At least 6 months of breast-feeding will be STRONGLY encouraged for all the children.
At the age of 4 months tolerance induction will be attempted by the daily intake of 1g wheat flour (100 mg gluten) during 8 weeks while continuing breast-feeding. No gluten will be given in these 8 weeks to control infants, but 1g. lactose as a placebo intervention.
A reduction of 50% of CD among the intervention group at the age of 3 years will be considered as an effective prevention.
- If the proposed early dietary intervention results in effective prevention of CD: development of new European guidelines for early nutrition in order to prevent the disease.
- Identification of the influence of early feeding on the development of coeliac disease in relation with immunological and genetical factors.
|- Main changes (audit trail)||17-Oct-2012: The trial has gain approval for prolongation with 1 year. The new planned enddate is therefore 27-Jul-2013 - NM|
|- RECORD||8-feb-2007 - 3-sep-2013|