Ulcerative Colitis and Crohn's Disease Observational Studies


Legacy

A long-term non-interventional registry to assess safety and effectiveness of HUMIRA® (adalimumab) in patients with moderately to severely active ulcerative colitis (UC)

Enrollment Status: UPCOMING

Study Coordinator: Siera Goodnight, (734) 647-1092, higginsSCteam@umich.edu

The purpose of this research study is to collect long-term safety information on HUMIRA® (adalimumab), a monoclonal antibody approved for the treatment of moderate to severely active ulcerative colitis (UC). Information will also be collected if subjects are using one of the two immunomodulator medications, azathioprine (AZA), and 6-mercaptopurine (6-MP).


PREDICT

A multicenter study evaluating a practical index score for subjects with Crohn’s dIsease assessing the absence of mucosal ulceration

Enrollment Status: UPCOMING

Study Coordinator: Siera Goodnight, (734) 647-1092, higginsSCteam@umich.edu

The primary purpose of this study is to evaluate whether three new measures which are composed of questions and laboratory data can predict damage to the lining of the intestines.  These measures will be compared to the endoscopy results.  New markers for inflammation will also be collected to determine whether or not the existing measures can be improved.  This study will also determine, based on the analysis of all microbes genes in your stool sample, whether there is a definite microbiota (microscopic organisms) profile connected with the activity of Crohn’s disease and evaluate whether determining this profile may improve Crohn’s disease management. Studying and analyzing all microbes’ genes is called metagenomics.

MARQUEE

Does mucosal healing matter for cinically quiescent ulcerative colitis?

Enrollment Status: UPCOMING

Study Coordinator: Siera Goodnight, (734) 647-1092, higginsSCteam@umich.edu

This study will determine how many patients with ulcerative colitis in clinical remission have signs of active disease on their routine surveillance colonoscopy with biopsies. This study will also determine if the colonoscopy and biopsy findings of routine surveillance colonoscopies can predict the risk of a disease flare over the next 1 year. Subjects will answer questionnaires prior to their scheduled surveillance colonoscopy. A video of their endoscopy procedure will be recorded and the biopsies taken from the procedure will be re-analyzed. Subjects will be contacted every 3 months during the follow year to monitor the possible occurrence of a flare.

CCFA CDI

Clostridium difficile infection (CDI) induces changes in the gut microbiome that lead to ulcerative colitis flares

Enrollment Status: OPEN

Study Coordinator: Katy Patten, (734) 615-4843, higginsSCteam@umich.edu

The long-term goal of this project is to identify what causes flares of ulcerative colitis (UC). Patients with UC can stay in remission for months or years, but the threat of a flare of disease is always present. We have little understanding of what actually triggers flares of UC, and few opportunities to study flares before they start. Several recent studies have elucidated the role of Clostridium difficile infection (CDI) in triggering flares in patients with UC, leading to extended hospital stays, more severe disease, and a high rate of colectomy. This is a prospective cohort study with longitudinal sampling of stool microbiome from UC patients with CDI, non-IBD patients with CDI, and UC patients with non-CDI flares.

We will use deep microbial 454 sequencing to determine whether specific changes in the gut microbiome in UC patients infected with Clostridium difficile are predictive of two adverse clinical outcomes in UC patients: UC flares induced by C. difficile infection, and recurrence of C. difficile infection.


PRIDE

Procalcitonin as a biomarker to distinguish an inflammatory bowel disease flare from Clostridium difficile infection

Enrollment Status: OPEN

Study Coordinator: Katy Patten, (734) 615-4843, higginsSCteam@umich.edu

The goal of this study is to identify a biomarker or combination of biomarkers that can help distinguish a flare of inflammatory bowel disease (IBD) from a bacterial infection with Clostridium difficile. Additionally, we hope to identify biomarkers that can help predict those patients most at risk for a severe disease course, including inpatient admission or progression to colectomy. This is a prospective observational study with single time-point sampling of both discarded stool and serum from 250 symptomatic outpatients with ulcerative colitis and suspected C. difficile infection, with a goal of obtaining 50 symptomatic patients with ulcerative colitis and C. difficile. We will also prospectively sample iscarded stool and serum from 100 symptomatic inpatients with ulcerative colitis and suspected C. difficile infection at the time of stool collection.


GEM Project

A multidisciplinary human study on the genetic, environmental and microbial interactions that cause inflammatory bowel disease

Enrollment Status: OPEN

Study Coordinator: Kay Sauder, (734) 647-2564, higginsSCteam@umich.edu

This study is for healthy first degree relatives of patients with Crohn’s and it is funded by the Crohn’s and Colitis Foundation of Canada (CCFC). Healthy volunteer participation includes one visit with a blood, stool, and urine sample, and a few surveys. A research team member will call the volunteer once every 6 months for the next 5 years to see if any new IBD symptoms have occurred.


Lycera

Inflammatory bowel disease (IBD) Lycera serum study

Enrollment Status: OPEN

Study Coordinator: Kelli Porzondek, (734) 764-0507, higginsSCteam@umich.edu

This is an exploratory study to test a novel biologic compound targeting circulating active T-cells on a blood sample from subjects with inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC). This study is based on preliminary data obtained by researchers in Italy showing that some activated T cells can be specifically killed by new drugs. We will explore the mechanism of action and basis for selectivity in this subset of cells for biomarker development. This study involves only a single blood draw.


Novel biomarkers of intestinal fibrosis in Crohn’s disease

Enrollment Status: OPEN

Study Coordinator: Kelli Porzondek, (734) 764-0507, higginsSCteam@umich.edu

The hypothesis of this study is to determine if blood-based biomarkers of intestine-specific fibrogenesis and fibrosis will identify and quantify fibrostenotic intestinal damage, providing prognostic value for complications of Crohn’s disease. The specific aims of this study are three-fold: to determine if levels of novel markers of intestinal inflammation discovered by proteomic analysis correlate with the presence and burden of fibrostenotic disease in patients with Crohn’s disease; to determine if identified biomarkers of fibrosis predict the long-term development of fibrosis and recurrent intestinal fibrostenotic disease in post-operative patients; and finally, to determine if identified biomarkers of intestinal inflammation provide unique prognostic and predictive disease monitoring information compared to other biomarkers of disease activity including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, and lactoferrin. Patients with Crohn’s disease who have active disease, intestinal narrowing, and who are scheduled for surgical resection will be recruited for this study.

BÜHLMANN calprotectin ELISA method comparison to predictive device for FDA clearance

Enrollment Status: OPEN

Study Coordinator: Kay Sauder,(734) 647-2564, higginsSCteam@umich.edu

An instrument was developed by BÜHLMANN to test calprotectin levels in stool specimens in Europe, however, it is not approved by the FDA for use in the United States. This instrument would aid in the diagnosis of inflammatory bowel diseases (IBD), as well as aid in the differentiation of active versus inactive inflammation of IBD, irritable bowel syndrome (IBS), and other functional bowel syndromes.