Retrospective Observing Refractory Celiac Disease in Germany
- Conditions
- Refractory Celiac Disease
- Registration Number
- DRKS00006871
- Lead Sponsor
- CED Service GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 53
Inclusion criteria follow the criteria to diagnose RCD:
Enteropathy with villous atrophy and crypt hyperplasia (Marsh IIIa/b/c); Clinically refractory to a gluten-free diet (GFD) for >1 year; If the patient's clinical situation requires medical treatment directed to treatment of malabsorption, definition of RCD can be based on diet-refractory states <1 year:
- enteral / parenteral nutrition
- local or systemic acting steroids
- azathioprin
- other medical therapy directed towards refractory sprue
low adherence to a GFD;
existence of other diseases, that provide an explanation for the clinical symptoms:
- Small intestinal Crohn´s disease
- Lambliasis
- Whipple´s disease
- Common variable immunodefiency (CVID)
- AIDS-associated enteropathy
- eosinophilic enteritis
- Autoimmune enteropathy
- Radiation-induced enteritis
- Intestinal tuberculosis
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary goal is to implement a Germany-wide Registry for Refractory Celiac Disease (RCD) patients.
- Secondary Outcome Measures
Name Time Method A questionnaire based observation trial ist o be performed associated with the identification of RCD patients. Physicians, treating RCD patients, will fullfill the questionnaire containing data of the chosen diagnostic and therapeutic RCD strategy.