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

Study Overview
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Brief Summary
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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.

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

Conditions
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Clostridium Difficile, Inflammatory Bowel Diseases

Intervention / Treatment
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* Diagnostic Test: Determination of serum anti-toxin Abs for C. difficile


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non immunosuppressed patients<br>without treatment or treated with Salicylates and that have not received immunosuppressive therapy, steroids, or biologics in the last 6 months. | Diagnostic Test: Determination of serum anti-toxin Abs for C. difficile<br> <br> * Other names: Stool culture for C. difficile;|
| Patients with immunosuppressive therapy<br>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. | Diagnostic Test: Determination of serum anti-toxin Abs for C. difficile<br> <br> * Other names: Stool culture for C. difficile;|
| Patients with biologic agents<br>in standard dosage at least the past 6 months and that have not received steroids in the previous 6 months. | Diagnostic Test: Determination of serum anti-toxin Abs for C. difficile<br> <br> * Other names: Stool culture for C. difficile;|
| Patients with steroid treatment<br>Must have received daily steroid treatment ≥ 20 mg for ≥ 2 weeks. | Diagnostic Test: Determination of serum anti-toxin Abs for C. difficile<br> <br> * Other names: Stool culture for C. difficile;|
| Healthy subjects<br>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. | Diagnostic Test: Determination of serum anti-toxin Abs for C. difficile<br> <br> * Other names: Stool culture for C. difficile;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Study the relationship between the different maintenance therapies for IBD and C. difficile anti-toxin Abs and asymptomatic carriers. |  | 0 days |