Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients

Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01560169

Enrollment

110

Registered

2012-03-22

Start date

2012-03-31

Completion date

2013-09-30

Last updated

2013-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

Celiac Disease, Coeliac Disease, Celiac Sprue, Keilakia Disease

Brief summary

This is an evaluation of celiac-specific patient reported outcome instruments in celiac disease patients.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* History of biopsy proven celiac disease * Adherence to a gluten-free diet (established patients only) * TG2 negative (established patients only) * TG2 positive (newly diagnosed patients only) * Signed informed consent

Exclusion criteria

* History of IgE-mediated reactions to gluten * Significant laboratory abnormalities * History of untreated or GI disease * Positive pregnancy test * Any medical condition which could adversely affect study participation

Design outcomes

Primary

Measure	Time frame	Description
Change in symptoms using patient reported outcome instruments	8 and 12 weeks	Sensitivity of the patient reported outcome instruments to detect change over time in celiac disease symptoms with and without a gluten challenge

Secondary

Measure	Time frame	Description
Safety - incidence of adverse events	8 and 12 weeks	Safety will be evaluated by incidents of adverse events including clinical significant laboratory evaluations and serious adverse events

Countries

Canada, United States

Outcome results