Multimodal Approach in IBD Patients

NCT01705522 | Unknown

• 1 other identifier: COL-GASTRO-3
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Clinical relapse

  clinical relapse as assessed by conventional scores for activity in IBD - Mayo or CDAI

  1 year

• Prevalence of NAFLD

  to assess the prevalence of nonalcoholic liver disease in IBD patients

  1 year

• prevalence of vitamin D deficiency

  to assess vitamin D deficiency and osteopenia among IBD patients

  1 year

Study Arms (1)

IBD patients

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients with IBD over 18 years of age, currently in clinical remission

You may qualify if:

• ulcerative colitis or Crohn's disease
• age over 18
• clinical remission
• signed informed consent

You may not qualify if:

• pregnant women
• refusal to sign informed consent

Sponsors & Collaborators

• Clinical Hospital Colentina: lead

Study Sites (1)

Colentina Clinical Hospital

Bucharest, 020125, Romania

RECRUITING

Related Publications (2)

• 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. doi: 10.1023/a:1018895500721.

  PMID: 9246063 BACKGROUND

• Voiosu T, Bengus A, Dinu R, Voiosu AM, Balanescu P, Baicus C, Diculescu M, Voiosu R, Mateescu B. Rapid fecal calprotectin level assessment and the SIBDQ score can accurately detect active mucosal inflammation in IBD patients in clinical remission: a prospective study. J Gastrointestin Liver Dis. 2014 Sep;23(3):273-8. doi: 10.15403/jgld.2014.1121.233.thv.

  PMID: 25267955 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and fecal samples

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Non-alcoholic Fatty Liver Disease; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Fatty Liver; Liver Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Theodor Voiosu, Md

  Clinical Hospital Colentina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theodor A Voiosu, MD

CONTACT

0040726732764; theodor.voiosu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology resident, Teaching Assistant

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 12, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

RO (1)