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 |
| Secondary identifying numbers | NTR890 |
- 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
Scientific
Leiden University Medical Centre
Department Of Pediatrics
P.O. Box 9600
Leiden
2300 RC
Netherlands
| M.L.Mearin_Manrique@lumc.nl |
Study information
| Study design | Randomised placebo-controlled parallel-group double-blinded multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 | 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 study start date | 01/01/2007 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 1000 (including participants from all centres) |
| 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
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Pediatrics
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/english/start_english.html#http://www.lumc.nl/english/start_english.html |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Government
European Commission (Belgium)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/10/2014 | Yes | No |
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.
