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

• Conditions: Clostridium Difficile; Inflammatory Bowel Diseases
• Interventions: Diagnostic Test: Determination of serum anti-toxin Abs for C. difficile

• Registration Number: NCT03889808
• Lead Sponsor: Hospital Universitari de Bellvitge

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Status Verified: 2019-03
• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-02
• Primary Completion: 2021-01
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with steroid treatment	Determination of serum anti-toxin Abs for C. difficile	Must have received daily steroid treatment ≥ 20 mg for ≥ 2 weeks.
Non immunosuppressed patients	Determination of serum anti-toxin Abs for C. difficile	without treatment or treated with Salicylates and that have not received immunosuppressive therapy, steroids, or biologics in the last 6 months.
Patients with biologic agents	Determination of serum anti-toxin Abs for C. difficile	in standard dosage at least the past 6 months and that have not received steroids in the previous 6 months.
Patients with immunosuppressive therapy	Determination of serum anti-toxin Abs for C. difficile	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.
Healthy subjects	Determination of serum anti-toxin Abs for C. difficile	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Universitari de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain