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NCT01705522 Clinical Trial

Multimodal Approach in IBD Patients

Ulcerative Colitis Clinical Trial

— MAID  

Official title:
Multimodal Approach in IBD Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01705522
Other study ID # COL-GASTRO-3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2012
Est. completion date October 2019

Study information
Verified date January 2019
Source Clinical Hospital Colentina
Contact Theodor A Voiosu, MD
Phone 0040726732764
Email theodor.voiosu@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators intend to assess the role of several biomarkers in the prediction of relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive score will be derived in order to assess the relapse risk at 1 year.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date October 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- ulcerative colitis or Crohn's disease

- age over 18

- clinical remission

- signed informed consent

Exclusion Criteria:

- pregnant women

- refusal to sign informed consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Romania Colentina Clinical Hospital Bucharest

Sponsors (1)
Lead Sponsor Collaborator
Clinical Hospital Colentina

Country where clinical trial is conducted

Romania, 

References & Publications (1)

Dionne S, Hiscott J, D'Agata I, Duhaime A, Seidman EG. Quantitative PCR analysis of TNF-alpha and IL-1 beta mRNA levels in pediatric IBD mucosal biopsies. Dig Dis Sci. 1997 Jul;42(7):1557-66. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical relapse clinical relapse as assessed by conventional scores for activity in IBD - Mayo or CDAI 1 year
Primary Prevalence of NAFLD to assess the prevalence of nonalcoholic liver disease in IBD patients 1 year
Primary prevalence of vitamin D deficiency to assess vitamin D deficiency and osteopenia among IBD patients 1 year
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