Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250146
Status:
TERMINATED
Last Update Posted:
2005-11-07
First Post:
2005-11-03
Brief Title:
Multicenter Study on the Toxicity of Gluten Traces in the Treatment of Celiac Disease
Sponsor:
Università Politecnica delle Marche
Organization:
Università Politecnica delle Marche
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2005-04
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:
None
Brief Summary:
The purpose of this study is to evaluate the toxicity of minute doses of gluten in the treatment of celiac disease a disorder characterized by permanent intolerance to dietary gluten
Detailed Description:
Treatment of celiac disease CD is based on the complete avoidance of gluten-containing products in the diet However it is not known whether tiny amounts of gluten are harmful for patients on long-term treatment This is an important issue as even a strict gluten-free diet GFD is usually contaminated by traces of gluten eg in wheat starch and processed food The aim of this study is to investigate the toxicity of the prolonged ingestion of gluten traces in treated CD patients This is a prospective placebo-controlled double-blind study Patients are adults with biopsy-proven CD on treatment with the GFD for at least 2 years During the study period their background daily gluten intake is kept lower than 5 mg After baseline evaluation patients continue their GFD and are assigned to ingest 0 mg 10 mg or 50 mg of daily gluten incorporated in a capsule for 90 days The following evaluations are performed both at baseline and after the micro-challenge clinical serological anti-transglutaminase and antigliadin antibodies and small intestine histology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None