Seroprevalence of Anti-bodies Against Clostridium Difficile Toxins and Prevalence of Asymptomatic Carriage of Clostridium Difficile in IBD Patients.

Hospital Universitari de Bellvitge500 enrolled

Overview

The objective of this study to evaluate the seroprevalence of anti-bodies against C. difficile toxins A and B and the asymptomatic carriage of C. difficile in IBD patients according to the need and type of immunosuppressive therapy. The ultimate goal is to identify, among IBD patients, those with the highest risk of CDI.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Clostridium Difficile Inflammatory Bowel Diseases

Interventions

Determination of serum anti-toxin Abs for C. difficileDIAGNOSTIC_TEST

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent * Diagnosed of IBD, either Crohn's disease or ulcerative colitis * Age: \>18 and \<65 years * Time since diagnoses of IBD ≥ 6 months * Present with the criteria included in any of the 4 specified groups in the study population Exclusion Criteria: * History of documented CDI * Active CDI at the moment of study inclusion * Any of the following immunosuppressive conditions: HIV infection, Liver cirrhosis, CKD stage IV, Receiving chemotherapy, Transplant (solid organ or hematological), Concomitant neoplasia, Hypogammaglobinemia.

Locations (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Prevalence of Clostridium difficile anti-toxin Abs in patients with IBD

Determination of serum anti-toxin Abs for C. difficile with ELISA (enzyme-linked immunosorbent assay). The concentration of C. difficile anti-toxin Abs will be categorized as: \< 25 percentile: Low, \>26 \< 75 percentiles: Intermediate, \>76 \<90 percentiles: High, \>91 percentile: Very high.

Time frame: 0 days

Prevalence of asymptomatic carrier of Clostridium difficile in patients with IBD

Stool testing for C. difficile as part of a multiple step algorithm: GDH (glutamate dehydrogenase), toxin EIA (enzyme immunoassay) test and C. difficile culture.

Time frame: 0 days

Study the relationship between the different maintenance therapies for IBD and C. difficile anti-toxin Abs and asymptomatic carriers.

Time frame: 0 days

Central Contacts

Clàudia Arajol, MD

CONTACT

+34932607500 carajol@bellvitgehospital.cat

Data from ClinicalTrials.gov

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