Multimodal Approach in IBD Patients

NCT ID: NCT01705522

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2019-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IBD patients

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Clinical Hospital Colentina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

dr. Theodor Alexandru Voiosu

Gastroenterology resident, Teaching Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Theodor Voiosu, Md

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Colentina

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Colentina Clinical Hospital

Bucharest, , Romania

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Romania

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Theodor A Voiosu, MD

Role: CONTACT

0040726732764

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Andreea Bengus, MD

Role: primary

0040744497626

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 9246063 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25267955 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COL-GASTRO-3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nutrition and Clinical Outcomes in IBD
NCT06550310 NOT_YET_RECRUITING
Bologna IBD Markers
NCT02580864 COMPLETED