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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03889808
• Other study ID #: JGC-INM-2014-01
• Status: Recruiting
• Start date: March 2014
• Est. completion date: December 2021

Study information

• Verified date: March 2019
• Source: Hospital Universitari de Bellvitge
• Contact: Clàudia Arajol, MD
• Phone: +34932607500
• Email: carajol[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clostridium Difficile
• Clostridium Infections
• Inflammatory Bowel Diseases

Intervention

Diagnostic Test:
• Determination of serum anti-toxin Abs for C. difficile

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0 days
Primary	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.	0 days
Primary	Study the relationship between the different maintenance therapies for IBD and C. difficile anti-toxin Abs and asymptomatic carriers.		0 days