Multimodal Approach in IBD Patients (MAID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01705522|
Recruitment Status : Recruiting
First Posted : October 12, 2012
Last Update Posted : January 31, 2019
|Condition or disease|
|Ulcerative Colitis Crohn's Disease Nonalcoholic Fatty Liver Disease (NAFLD) Vitamin D Deficiency|
Patients with a confirmed diagnosis of IBD will be prospectively assessed on a yearly basis in order to assess relapse risk factors.
Disease activity will be assessed using the Mayo score for UC patients and CDAI for Crohn's disease and endoscopic activity will be assessed using the Mayo endoscopic subscore for UC patients and the Simple Endoscopic Score for Crohn's Disease for CD patients.
Serum and fecal biomarkers will be obtainted at each study visit (C-reactive protein, fecal calprotectin).
Data about current and past medication for IBD will also be gathered.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Multimodal Approach in IBD Patients|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||October 2019|
patients with ulcerative colitis or crohn's disease, in remission
- Clinical relapse [ Time Frame: 1 year ]clinical relapse as assessed by conventional scores for activity in IBD - Mayo or CDAI
- Prevalence of NAFLD [ Time Frame: 1 year ]to assess the prevalence of nonalcoholic liver disease in IBD patients
- prevalence of vitamin D deficiency [ Time Frame: 1 year ]to assess vitamin D deficiency and osteopenia among IBD patients
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705522
|Contact: Theodor A Voiosu, MDemail@example.com|
|Colentina Clinical Hospital||Recruiting|
|Bucharest, Romania, 020125|
|Contact: Andreea Bengus, MD 0040744497626 firstname.lastname@example.org|
|Principal Investigator: Theodor A Voiosu, MD|
|Principal Investigator:||Theodor Voiosu, Md||Clinical Hospital Colentina|