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Multimodal Approach in IBD Patients (MAID)

C

Clinical Hospital Colentina

Status

Unknown

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT01705522
COL-GASTRO-3

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

IBD patients
Description:
patients with ulcerative colitis or crohn's disease, in remission

Trial contacts and locations

1

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Central trial contact

Theodor A Voiosu, MD

Data sourced from clinicaltrials.gov

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