Seroprevalence of Anti-bodies Against Clostridium Difficile Toxins and Prevalence of Asymptomatic Carriage of Clostridium Difficile in IBD Patients.
NCT ID: NCT03889808
Last Updated: 2019-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2014-03-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Non immunosuppressed patients
without treatment or treated with Salicylates and that have not received immunosuppressive therapy, steroids, or biologics in the last 6 months.
Determination of serum anti-toxin Abs for C. difficile
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.
Determination of serum anti-toxin Abs for C. difficile
Patients with biologic agents
in standard dosage at least the past 6 months and that have not received steroids in the previous 6 months.
Determination of serum anti-toxin Abs for C. difficile
Patients with steroid treatment
Must have received daily steroid treatment ≥ 20 mg for ≥ 2 weeks.
Determination of serum anti-toxin Abs for C. difficile
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.
Determination of serum anti-toxin Abs for C. difficile
Interventions
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Determination of serum anti-toxin Abs for C. difficile
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Claudia Arajol Gonzalez
Principal Investigator
Principal Investigators
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Jordi Guardiola, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge
Locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JGC-INM-2014-01
Identifier Type: -
Identifier Source: org_study_id
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