Research

Yale University is one of six genetic research centers created by the National Institute of Diabetes, Digestive and Kidney diseases (NIDDK) seeking to advance the discovery of genes influencing an individuals’ risk for developing Crohn’s disease and ulcerative colitis.

For more information on the Yale IBD Genetics Consortium click here.

Here at the Yale IBD Program, we believe research is an integral component of achieving the highest quality care. The Yale IBD Program is uniquely suited to offer state of the art research to the patients who are evaluated. Both clinicians and researchers work together for the patient’s best interest. For us, the goal of research is three-fold: to improve clinical therapy, to improve patient outcomes, and to increase our understanding of the disease. Our research interests and studies fall into two categories, Clinical and Translational. All research is approved through Yale Institutional Review Board (IRB).

Open Clinical Trials

  1. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral CP-690,550 as an Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (UC)
    Tofacitinib Induction
    The purpose of this research study is to compare the effects of CP-690,550 (Tofacitinib) to a placebo in patients with ulcerative colitis in inducing remission in these patients. CP-690,550 blocks a group of enzymes (janus kinases), which act like a gate into the cells of the immune system. By blocking these enzymes, the cells of the immune system are expected to produce fewer chemicals believed to cause bowel inflammation in UC. In order to be eligible for this study, participants must be 18 years of age, have a diagnosis of UC for greater than 4 months, have failed either oral corticosteroids, 6MP, Azathioprine, Humira or Remicade, and must meet other criteria which will be discussed at the screening visit. Eligible participants in this study will have a 4 in 5 (80%) chance of receiving CP-690,550. Based on the results of this study, participants may qualify to enter a maintenance or extension study. Principal Investigator: Dr. Ioannis Oikonomou. HIC #1211011128 . Status - Enrolling
  2. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of Oral CP-690,550 as a Maintenance Therapy in Subjects with Ulcerative Colitis (UC)
    Tofacitinib Maintenance
    The purpose of this research study is to compare the effects of CP-690,550 (Tofacitinib) to a placebo in patients with ulcerative colitis, and to determine how effective it may be as a maintenance treatment for UC. Participants will be eligible for this study if they participated in the Tofacitinib induction study and achieved clinical response. In this study, participants will have a 67% (2 in 3) chance of receiving CP 690,550, and 33% (1 in 3) chance of receiving placebo. After completing this study, participants may be given the option to participate in a long-term extension study. Principal Investigator: Dr. Ioannis Oikonomou. HIC #1211011129. Status - Not yet enrolling
  3. A Multicenter, Open-Label Study of CP-690,550 in Subjects with Moderate to Severe Ulcerative Colitis (UC)
    Tofacitinib Open Label
    The purpose of this research study is to assess the long term safety, tolerability and effectiveness of CP-690,550 (Tofacitinib) in patients with ulcerative colitis. Participants must have been previously enrolled in the induction or maintenance study of Tofacitinib in order to be eligible. This is an open label study and all patients will receive either 5 mg or 10 mg CP-690,550 twice a day, depending on the status of their UC at the baseline visit. Principal Investigator: Dr. Ioannis Oikonomou. HIC #1211011130. Status - Not yet enrolling
  4. A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy
    Uste Induction (UNITI)
    A study to determine whether treatment with ustekinumab (Stelara) improves symptoms of Crohn’s disease. For this research study, participants must have a diagnosis of Crohn’s disease for at least 3 months, they must have failed or been intolerant to at least one anti–TNF medication (Humira, Remicade, or Cimzia), they must be 18 years of age or older, and must meet other screening criteria which will be discussed at the screening visit. Two groups will receive a single intravenous administration of ustekinumab (Stelara) and one group will receive placebo. Depending on the response to treatment during this study, the participants might be eligible to enter a maintenance clinical study (IMUNITI). Principal Investigator: Dr. Ioannis Oikonomou. HIC #1105008530. Status - Closed to enrollment
  5. A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease (IMUNITI)
    Uste Maintenance
    A study to determine whether treatment with ustekinumab (Stelara) improves symptoms of Crohn’s disease over the long-term. This study especially focuses on how the response of the drug can be maintained in those who experienced improvement after the original treatment. Participants in this study must have first completed the induction study. Section one of this study will last 44 weeks from the first visit of this study and if a patient responds to treatment, he/she will be eligible to continue to receive study agent in a long term extension of up to 3 additional years. Principal Investigator: Dr. Ioannis Oikonomou. HIC #1106008632. Status -Closed to enrollment

Translational/Basic Research

  1. Genetics of Inflammatory Bowel Disease.Genetic information is analyzed to help us identify and better understand the way in which IBD manifests and how certain genetic traits contribute to this manifestation. Subjects from our study have already contributed to identifying over 30 genes that influence the development of IBD. Yale leads the NIDDK Inflammatory Bowel Disease Genetics Consortium (IBDGC) of six universities. A short family history and small blood draw are required. Principal Investigators: Drs. Judy H. Cho, Deborah Proctor, Ioannis Oikonomou, and Clara Abraham. (HIC # 0607001669) Status - Enrolling
  2. IBD Immune Responses. Understanding changes of immune responses and immune pathways in patients with IBD. The goals of these projects are to define changes in expression of genes, and in immunological pathways and responses in patients with Crohn's disease and ulcerative colitis by examining immune cells from the blood and intestine of patients with IBD. Requires a small blood sample. Principal Investigators: Drs. Clara Abraham and Judy H. Cho. (HIC # 0607001669) Status - Enrolling
  3. IBD Microbiome Study. A strategy to understand the microbial components of the human genetic and metabolic landscape and how they contribute to normal physiology and predisposition to IBD. Investigating the interrelationships between diet, lifestyle, intestinal bacteria, and genetic makeup for people with IBD. Involves diet questionnaire, phenotype form, a small blood sample and stool sample. Principal Investigators: Drs. Judy H. Cho, Deborah Proctor, Ioannis Oikonomou, and Clara Abraham. (HIC # 0607001669) Status - Not yet enrolling

Interested Participants

If you would like more information about our research studies, please call Elizabeth Ruggiero at 203-785-7573 or Annie Coe at 203-785-4576. Additionally, you can send us an email at ibd@yale.edu.

Participation in any research program is strictly voluntary and whether or not a patient participates does not alter how and when he or she is treated.

Closed Clinical Trials

  • A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults with Moderate-to-Severe Crohn's Disease
  • Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Remicade (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection who are at Increased Risk of Recurrence
  • Determinants of Quality of Life in Patients with Inflammatory Bowel Disease
  • Abbott Crohn’s Registry