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

Catalan Institute of Health

Status: Unknown

Conditions: Inflammatory Bowel Diseases; Clostridium Difficile

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

Study type: Observational

Funder types: Other

Identifiers

NCT03889808

JGC-INM-2014-01

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

500 participants in 5 patient groups

Non immunosuppressed patients

Description:

without treatment or treated with Salicylates and that have not received immunosuppressive therapy, steroids, or biologics in the last 6 months.

Treatment:

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

Patients with immunosuppressive therapy

Description:

Azathioprine, 6-Mercaptopurine, Methotrexate in standard dosage at least the past 6 months and that have not received steroids or biologics in the last 6 months.

Treatment:

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

Patients with biologic agents

Description:

in standard dosage at least the past 6 months and that have not received steroids in the previous 6 months.

Treatment:

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

Patients with steroid treatment

Description:

Must have received daily steroid treatment ≥ 20 mg for ≥ 2 weeks.

Treatment:

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

Healthy subjects

Description:

A healthy subject is defined as not having and immunosuppressive underlying condition, not receiving immunosuppressive therapy, has not received antibiotic treatment in the last 6 months, has no past C. difficile infections and has not been in contact with the health care system or hospitalized in the previous 6 months.

Treatment:

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