Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Boston Medical Center
Sponsor:
Collaborators:
Cepheid
Optimer Pharmaceuticals
Information provided by (Responsible Party):
Francis Farraye, MD, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01813500
First received: March 15, 2013
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

The inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease (CD) are chronic conditions affecting approximately 1.4 million Americans. The burden of Clostridium difficile infection (CDI), a frequent cause of infectious diarrhea is mediated by toxins A and B and is increasing faster in IBD patients, than the general population. Clinically, CDI in patients with IBD leads to a range of clinical syndromes from symptomless carriage, to severe life threatening colitis, colectomy and death.

This pilot study will look at the relationship between IBD and this variable host immune response. Clostridium difficile colonization (asymptomatic carrier state) is lower in the IBD population than in the general population. In the general population, high antitoxin titers have been linked with colonization and low antitoxin titers with recurrent disease. The investigators hypothesize that patients with IBD will have a lower Clostridium difficile colonization and will have lower antibody titers than the control group. Additionally those with lower titers will have an increased risk of developing CDI.

In Aim 1 the investigators will determine Clostridium colonization in IBD subjects by stool study (including CD, UC and UC patients after IPAA) compared to non-IBD subjects (controls). In Aim 2 the investigators will compare antitoxin titers in these IBD subjects compared to controls. In Aim 3 the investigators will follow these subjects for 12 months and calculate the incidence of CDI in patients with IBD compared to controls and associations with anti-toxin titers.


Condition Intervention
Crohn's Disease
Ulcerative Colitis
Clostridium Difficile
Inflammatory Bowel Disease
Other: Blood and stool sample

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Colonization [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Determine Clostridium colonization in IBD patients during clinical remission and during flares (including CD, UC and UC patients after IPAA) compared to controls


Secondary Outcome Measures:
  • Incidence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Determine the incidence of CDI in patients with IBD (including CD, UC and UC patients after IPAA) compared to controls and correlate to anti-toxin titer levels using the methods as outlined above


Biospecimen Retention:   Samples Without DNA

Serum, stool


Estimated Enrollment: 400
Study Start Date: October 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IBD Patients
Subjects with Crohn's Disease or Ulcerative colitis.
Other: Blood and stool sample
Subjects are asked to provide a blood sample (6 to 10cc) and a stool sample. An additional blood sample will be requested if the subject has a flare.
Control Subjects
Subjects without Crohn's Disease or Ulcerative Colitis
Other: Blood and stool sample
Subjects are asked to provide a blood sample (6 to 10cc) and a stool sample. An additional blood sample will be requested if the subject has a flare.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects with Crohn's Disease and Ulcerative Colitis or healthy controls.

Criteria

Inclusion Criteria:

  1. All subjects must be 18 years of age or older, able to provide written informed consent, and able to comply with the requirements of the study.
  2. All subjects must speak English. Non-English subjects are not included because of lack of funding for interpreter services and clinical resources could not be used for research purposes.
  3. For Control Group only: Non-IBD subject seen in CDD during routine visit or on inpatient consult service
  4. For IBD Group Only: Chart history of IBD (either UC or CD) confirmed by colonoscopy, pathology or gastroenterology clinical judgment

Exclusion Criteria:

  1. Any subject planning on moving out of the area in the next year
  2. Any patient not able to give informed consent
  3. Any subject unwilling or not able to give stool sample upon enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813500

Contacts
Contact: Steven K Knapp, BA 617-638-6527 steven.knapp@bmc.org
Contact: Adam Berg, MD 617-638-6116 adam.berg@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Steven K Knapp, BA    617-638-6527    steven.knapp@bmc.org   
Principal Investigator: Francis A Farraye, MD, MSc         
Sponsors and Collaborators
Boston Medical Center
Cepheid
Optimer Pharmaceuticals
Investigators
Principal Investigator: Francis A Farraye, MD Boston Medical Center Department of Gastroenterology
  More Information

Publications:
Responsible Party: Francis Farraye, MD, Principal Investigator, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01813500     History of Changes
Other Study ID Numbers: CDI and IBD
Study First Received: March 15, 2013
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Colitis
Colitis, Ulcerative
Crohn Disease
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014