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

NCT01813500 | Completed DMC

• 1 other identifier: H-31226
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn's Disease; Ulcerative Colitis; Clostridium Difficile; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Colonization

  Determine Clostridium colonization in IBD patients during clinical remission and during flares (including CD, UC and UC patients after IPAA) compared to controls

  12 Months

Secondary Outcomes (1)

• Incidence

  12 months

Study Arms (2)

IBD Patients

Subjects with Crohn's Disease or Ulcerative colitis. IBD patients will be asked to provide a blood and stool sample.

Other: Blood and stool sample

Control Subjects

Subjects without Crohn's Disease or Ulcerative Colitis. Controls will also be asked to provide a blood and stool sample.

Other: Blood and stool sample

Interventions

Blood and stool sample OTHER

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; IBD Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• Cepheid: collaborator
• Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• Berg AM, Kelly CP, Farraye FA. Clostridium difficile infection in the inflammatory bowel disease patient. Inflamm Bowel Dis. 2013 Jan;19(1):194-204. doi: 10.1002/ibd.22964.

  PMID: 22508484 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, stool

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Francis A Farraye, MD

  Boston Medical Center Department of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 19, 2013
• Study Start: October 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

US (1)