Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04593888
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2020-10-13
Brief Title:
Gluten Reduction and Risk of Celiac Disease
Sponsor:
Lund University
Organization:
Lund University
Study Overview
Official Title:
Gluten Reduction After Infancy and Risk of Celiac Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRAIN
Brief Summary:
Celiac disease shares many features of other autoimmune diseases such as type 1 diabetes Recently it was published that higher amounts of gluten intake increased the risk for celiac disease Optimal amounts of gluten to be introduced during weaning have not yet been established The aim is to investigate if a gluten-restricted diet eg below 3 gram per day during the first 3 years of life will reduce the risk of develop CDA and IA in genetically predisposed children by the age of 7 years Children who screened positive for HLA DQ2X X is neither DQ2 nor DQ8 in the GPPAD-02 ASTR1D ClinicalTrialsgov Identifier NCT03316261 screening will be contacted by a study nurse
Detailed Description:
Gluten is a complex mixture of proteins mainly gliadin and glutenin rich in proline and glutamine amino acids which make these proteins resistant to complete degradation by enzymes in the small intestinal Intolerance to gluten leads to inflammation of the intestinal epithelium and villous atrophy a disorder called celiac disease Celiac disease shares many features of other autoimmune diseases such as type 1 diabetes T1D First celiac disease is associated with certain HLA genotypes of whom 95 of all patients with celiac disease carry the haplotypes DQA10501-DQB10201 abbreviated DQ2 and the reminder 5 DQA10301-DQB10302 abbreviated DQ8 There is a gene dose effect of HLA-DQ on the risk of develop celiac disease 20 of the children homozygous for HLA-DQ2DQ2 will develop celiac disease by 10 years of age Second celiac disease is also strongly associated with the presence of autoantibodies directed against tissue transglutaminase tTGA that occurs in 100 of children with celiac disease Timing of gluten introduction and breastfeeding duration have previously been proposed to influence risk for celiac disease However based on the results from the multinational birth cohort study The Environmental determinants of Diabetes in the Young TEDDY study and other observational studies timing of gluten introduction seems not associated with celiac disease in genetically at-risk children In an RCT introduction of small amounts of gluten at the age of 4-6 months did not reduce the risk for celiac disease by the age of 3 years in genetically at-risk children Current international infant feeding recommendations recommend that gluten is introduced into the infants diet anytime between 4-12 months of age and that consumption of large quantities of gluten should be avoided during the first month after gluten introduction and during infancy Recently the TEDDY study published that higher amounts of gluten intake increased the risk for celiac disease which have been confirmed in two other observational cohort studies In the TEDDY study daily gluten intake was associated with higher increased risk of developing persistently positive tTGA a definition coined celiac disease autoimmunity CDA as well as with celiac disease for every 1-gday increase in gluten intake Optimal amounts of gluten to be introduced during weaning have not yet been established It is well known that an overlap between celiac disease and T1D exists most likely due to shared genetic risks of HLA-DQ2 andor DQ8 in both disorders Prospective studies in infants genetically predisposed to T1D and celiac disease showed that antibody positivity to both disorders begins in the first 1-3 years of life The study aim is to investigate if a gluten-restricted diet during the first 3 years of life will reduce the risk of develop CDA and IA in genetically predisposed children by the age of 7 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None