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Multimodal Approach in IBD Patients

Multimodal Approach in IBD Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01705522
Acronym
MAID
Enrollment
50
Registered
2012-10-12
Start date
2012-10-31
Completion date
2019-10-31
Last updated
2019-01-31

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

Conditions

Crohn's Disease, Nonalcoholic Fatty Liver Disease (NAFLD), Ulcerative Colitis, Vitamin D Deficiency

Keywords

IBD, ulcerative colitis, Crohn's disease, NAFLD, biomarkers, vitamin D

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Clinical Hospital Colentina
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical relapse1 yearclinical relapse as assessed by conventional scores for activity in IBD - Mayo or CDAI
Prevalence of NAFLD1 yearto assess the prevalence of nonalcoholic liver disease in IBD patients
prevalence of vitamin D deficiency1 yearto assess vitamin D deficiency and osteopenia among IBD patients

Countries

Romania

Contacts

Primary ContactTheodor A Voiosu, MD
theodor.voiosu@gmail.com0040726732764

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026