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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03889808

Enrollment

500

Registered

2019-03-26

Start date

2014-03-31

Completion date

2021-12-31

Last updated

2019-04-02

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

Conditions

Clostridium Difficile, Inflammatory Bowel Diseases

Brief summary

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.

Interventions

DIAGNOSTIC_TESTDetermination of serum anti-toxin Abs for C. difficile

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of Clostridium difficile anti-toxin Abs in patients with IBD	0 days	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.
Prevalence of asymptomatic carrier of Clostridium difficile in patients with IBD	0 days	Stool testing for C. difficile as part of a multiple step algorithm: GDH (glutamate dehydrogenase), toxin EIA (enzyme immunoassay) test and C. difficile culture.
Study the relationship between the different maintenance therapies for IBD and C. difficile anti-toxin Abs and asymptomatic carriers.	0 days	—

Countries

Spain

Contacts

Primary ContactClàudia Arajol, MD

carajol@bellvitgehospital.cat+34932607500

Outcome results

None listed

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