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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases; Clostridium Difficile
• Intervention / Treatment: Diagnostic test: Determination of serum anti-toxin Abs for C. difficile

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • Hospital Universitari de Bellvitge
      • Contact: Claudia Arajol, MD; Email: carajol@bellvitgehospital.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study would include 400 patients with IBD (Crohn's disease and ulcerative colitis).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non immunosuppressed patients; 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; Other Names: Stool culture 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.	Diagnostic test: Determination of serum anti-toxin Abs for C. difficile; Other Names: Stool culture 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.	Diagnostic test: Determination of serum anti-toxin Abs for C. difficile; Other Names: Stool culture for C. difficile
Patients with steroid treatment; Must have received daily steroid treatment ≥ 20 mg for ≥ 2 weeks.	Diagnostic test: Determination of serum anti-toxin Abs for C. difficile; Other Names: Stool culture 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.	Diagnostic test: Determination of serum anti-toxin Abs for C. difficile; Other Names: Stool culture for C. difficile

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Investigators: Principal Investigator: Jordi Guardiola, MD, Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Inflammatory Bowel Diseases; Clostridium Infections; Physiological Effects of Drugs; Immunologic Factors; Antitoxins
• Other Study ID Numbers: JGC-INM-2014-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No