Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients
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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 |
- 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
- 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 |
Subjects with Crohn's Disease and Ulcerative Colitis or healthy controls.
Inclusion Criteria:
- 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.
- 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.
- For Control Group only: Non-IBD subject seen in CDD during routine visit or on inpatient consult service
- For IBD Group Only: Chart history of IBD (either UC or CD) confirmed by colonoscopy, pathology or gastroenterology clinical judgment
Exclusion Criteria:
- Any subject planning on moving out of the area in the next year
- Any patient not able to give informed consent
- Any subject unwilling or not able to give stool sample upon enrollment
Contacts and Locations| Contact: Steven K Knapp, BA | 617-638-6527 | steven.knapp@bmc.org |
| Contact: Adam Berg, MD | 617-638-6116 | adam.berg@bmc.org |
| 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 | |
| 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 Intestinal Diseases Colitis Colitis, Ulcerative Crohn Disease Ulcer Clostridium Infections |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 23, 2013