Ongoing Clinical Research at UNC

IBD Research Studies helping patients with Ulcerative Colitis and Crohn's Disease.

Crohn's Disease Icon Crohn's Disease Research |Ulcerative Colitis Icon Ulcerative Colitis Research |Healthy Volunteers Icon Healthy Volunteers Accepted

 


Risk Factors for Skin Cancer in Patients with Inflammatory Bowel Disease     Crohn's Disease IconUlcerative Colitis Icon

Patients with inflammatory bowel disease (IBD) may be at risk for skin cancer, this is a research study to determine those risks in the instance of immunosuppression therapy. Patients considering starting immunosuppression therapy will complete a questionnaire regarding their risk for skin cancer. They will be given a full exam by a certified Dermatologist, and then will complete a photosensitivity test on an unexposed area of skin. This photosensitivity test will then be repeated after the patient starts immunosuppression therapy, three to twelve months after the first test.

Patients must be at least 18 years of age and have a lighter skin tone. Patients should not be pregnant, not have been on immunosuppressive medications in the past 12 months, and do not use tanning beds.

 

Microbiome 3B - The CCFA IBD Families Fecal Microbiome Demonstration Study   Crohn's Disease IconHealthy Volunteers Icon

This research study involves the entire family; a patient with Crohn's Disease, 2 healthy parents, and one healthy sibling. Microbiome 3B is researching the potential interactions of genetic factors and intestinal bacteria, which might influence the risk for the development of Crohn’s disease.

Patients must be between ages 14 to 50, with a sibling at least 8 years old and two parents without Crohn's Disease.

GEM Project: A Multidisciplinary Human Study on the Genetic, Environmental and Microbial Interactions that Cause Inflammatory Bowel Disease Crohn's Disease IconHealthy Volunteers Icon

The GEM Project is a research study attempting to determine possible causes for Crohn’s Disease by following healthy individuals who are at a higher risk for developing the disease over time. This study is for healthy individuals who have a sibling and/or parent with Crohn’s Disease. To find out more information, click here: http://www.gemproject.ca.

Healthy patients must be between ages 6 and 35, and have either a sibling or parent with Crohn's Disease.

SHARE: Translational Studies in Inflammatory Bowel Disease   Crohn's Disease IconUlcerative Colitis Icon

SHARE is an observational research study that will build a registry of patients recently diagnosed with IBD. Patients will be recruited and asked to provide clinical information and donate blood samples. Approximately 10,500 patients will be enrolled over a 5-year period at 7 investigational sites. Follow-up will occur every 6 months until the study ends. The goal of the study is to create a database of clinical information and a repository of biological specimens for genetic, molecular and microbiological research to better understand IBD and help develop new therapies.

Patients must be at least 18 years of age and have been diagnosed with Crohn's disease, UC, or Indeterminate Colitis within the last 4 years.

Division of Digestive Diseases Inflammatory Bowel Disease Database   Crohn's Disease IconUlcerative Colitis Icon

The purpose of this research study is to develop a research database of patients with inflammatory bowel disease for the purpose of providing the investigators in the Division of Gastroenterology and Hepatology with the sources of serum and tissue samples and clinical information for basic research and clinical studies of various inflammatory bowel diseases.

All IBD patients ages 18 to 80 may enroll.

 

A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease (PIANO)   Crohn's Disease IconUlcerative Colitis Icon

A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease study is being conducted at the University of California San Francisco and 30 other sites around the United States who are part of the CCFA Clinical Alliance. The aim of this study is to determine the effect of medication use and disease activity on the outcome of pregnancy among women with IBD up to one year from birth. We are looking for 660 pregnant women to enroll in the duration of 3 years.

Patients ages 18 to 45 may enroll. This study is for all pregnant women with IBD diagnosis who are taking biologics medicines and immunosuppressants.

 

CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring   Crohn's Disease Icon

The purpose of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events in patients with Crohn's Disease(CD) treated with TYSABRI® (Natalizumab).

Patients must be at least 18 years of age. Patients must already be prescribed TYSABRI® within the TOUCH prescribing program, and must have had at least one infusion but no more than six infusions.

 

SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry   Crohn's Disease Icon

The purpose of this study is to monitor safety outcomes of patients who have taken Cimzia® as compared to a non- Cimzia® control population. The SECURE Registry's target enrollment is 4000 patients and it's objective is to monitor patients for approximately 10 years.

Patients must be at least 7 years of age to enroll. The study accepts patients about to receive treatment with Cimzia® as part of pre-existing management plan for Crohn's Disease or has already been receiving treatment with Cimzia® for < 6 months, or control patients about to receive treatment with any other medication as part of a pre-existing management plan for Crohn's Disease or has already been receiving treatment (previous Cimzia® treatment is prohibited).

 

PUCCINI: Prospective Cohort of Ulcerative Colitis and Crohn’s Disease Patients Undergoing Surgerty to Identify Risk Factors for Post-Operative Infection   Crohn's Disease IconUlcerative Colitis Icon

The purpose of this research study is to determine whether exposure to anti-TNF antibodies is an independent risk factor for post-operative infection in CD and UC. Also, to explore other possible risk factors for post-operative infection.

Once a potential subject is identified, s/he will be approached by the study coordinator or investigator, and asked to participate. Eligible participants will then undergo a baseline interview (during hospitalization prior to surgery and up to 4 days post-surgery) and a follow-up telephone interview (30 days after surgery +/- 7 days).

Patients must be at least 18 years of age, have an IBD diagnosis, and plan to have abdominal surgery.

For more information regarding these research studies and ongoing treatment studies, please contact an IBD Study Coordinator.

 

For UNC Research Staff - Access our IBD Trials Webpage here.