NCT00250146

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
Last Updated

November 7, 2005

Status Verified

April 1, 2005

First QC Date

November 3, 2005

Last Update Submit

November 3, 2005

Conditions

Celiac Disease

Keywords

Celiac DiseaseGlutenToxicitySmall bowel morphometry

Outcome Measures

Primary Outcomes (5)

  • Villous Height/Crypt Depth ratio on small intestinal biopsy

  • Intraepithelial lymphocyte coun on small intestinal biopsy

  • changes in serum IgA class anti-trasnglutaminase antibodies

  • changes in serum IgG class anti-gliadin antibodies

  • clinical symptoms

Interventions

Gluten (behaviour)BEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults with biopsy-proven celiac disease on a gluten-free diet for at least 2 years and in apparent good health -

You may not qualify if:

  • patients younger than 18 years old;
  • poor compliance to the gluten-free diet;
  • abnormal results at the baseline evaluation (positivity of anti-tissue transglutaminase (tTG) antibodies and/or definitely abnormal small intestinal biopsy;
  • associated conditions, such as selective IgA deficiency or other autoimmune diseases -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Department of Pediatrics

Ancona, Ancona, 60123, Italy

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

Glutens

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProlaminsGrain ProteinsPlant ProteinsProteinsAmino Acids, Peptides, and ProteinsSeed Storage Proteins

Study Officials

  • Carlo Catassi, M.D.

    Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

February 1, 2001

Study Completion

March 1, 2005

Last Updated

November 7, 2005

Record last verified: 2005-04

Locations

IT(1)