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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non immunosuppressed patients | without treatment or treated with Salicylates and that have not received immunosuppressive therapy, steroids, or biologics in the last 6 months. |
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| Patients with immunosuppressive therapy | 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. |
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| Patients with biologic agents | in standard dosage at least the past 6 months and that have not received steroids in the previous 6 months. |
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| Patients with steroid treatment | Must have received daily steroid treatment ≥ 20 mg for ≥ 2 weeks. |
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| Healthy subjects | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Determination of serum anti-toxin Abs for C. difficile | Diagnostic Test |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study would include 400 patients with IBD (Crohn's disease and ulcerative colitis).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clà udia Arajol, MD | Contact | +34932607500 | 8091 | carajol@bellvitgehospital.cat |
| Name | Affiliation | Role |
|---|---|---|
| Jordi Guardiola, MD | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
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|
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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