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NCT01813500 · ClinicalTrials.gov registry record
Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients
A clinical trial, sponsored by Boston Medical Center.
- Completed
- Registry status
- 400
- Enrollment target
NCT01813500: Completed study, sponsored by Boston Medical Center.
NCT01813500 is a clinical trial that has completed, run by Boston Medical Center. The registered enrollment target is 400 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01813500 has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- 400 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Determine Clostridium colonization in IBD patients during clinical remission and during flares (including CD, UC and UC patients after IPAA) compared to controls
Interventions
- OTHER Blood and stool sample
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-04 |
What the finished NCT01813500 record still lists
NCT01813500 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Blood and stool sample is the first listed.
NCT01813500 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01813500 about?
NCT01813500 is a clinical study titled "Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients". 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 f...
What is the current status of trial NCT01813500?
This trial is currently completed. The enrollment target is 400 participants. The study started on 2011-10. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01813500?
The interventions under investigation include: Blood and stool sample (OTHER).
Who is sponsoring clinical trial NCT01813500?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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