Detection of Immunotoxic Gluten Peptides in Feces | NCT01478867

Studies
Detection of Immunotoxic Gluten Peptides in Feces

NCT01478867

Sponsor

University of Seville

Status

Completed

Last Update Posted

Nov 24, 2011Estimated

Enrollment

53Actual

Phase

Not provided

Conditions

Celiac Disease

Interventions

Detection of gluten in feces

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Not provided

Completion Date

Jul 2011Actual

First Submitted Date

Nov 21, 2011

First Submission Date that Met QC Criteria

Nov 22, 2011

First Posted Date

Nov 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2011

Last Update Posted Date

Nov 24, 2011Estimated

Name	Class
Instituto Hispalense de Pediatría, Seville, Spain	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to monitor of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces.

Detailed Description

Certain immunotoxic peptides from gluten are resistant to gastrointestinal digestion and can interact with celiac patient factors to trigger immunological response. Gluten-free diet (GFD) is the only effective treatment for celiac disease (CD) and its compliance should be monitored to avoid accumulative damage. However, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available.

This study assesses the capacity to determine the gluten ingestion, and to monitor the GFD compliance in celiac patients by detection of gluten and gliadin 33-mer equivalent peptidic epitopes in human feces.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Celiac patients			Other: Detection of gluten in feces

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Detection of gluten in feces	Other	Detection of Gluten in Feces	Celiac patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Monitoring of gluten-free diet compliance in celiac patients	Usual gluten diet for celiac (home diet not modified for this trial)	April-July 2011 (3 months)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Celiac patient
1-12 years old
Written informed consent

Exclusion Criteria:

Known inflammatory bowel diseases
Participation in any other studies involving investigational concomitantly or within two weeks prior to entry into the study and during the course of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

12 Years

Standard Ages

Child

Study Population

Celiac patients, 1-12 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carolina Sousa, Professor	University of Seville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville		Seville	Seville	41012	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18258632	Background	Moron B, Cebolla A, Manyani H, Alvarez-Maqueda M, Megias M, Thomas Mdel C, Lopez MC, Sousa C. Sensitive detection of cereal fractions that are toxic to celiac disease patients by using monoclonal antibodies to a main immunogenic wheat peptide. Am J Clin Nutr. 2008 Feb;87(2):405-14. doi: 10.1093/ajcn/87.2.405.
18509534	Background

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D003672	Defecation
D055050	Diet, Gluten-Free

ID	Term
D004068	Digestive System Physiological Phenomena
D055688	Digestive System and Oral Physiological Phenomena
D004035	Diet Therapy
D044623	Nutrition Therapy