Crohn's Disease and Ulcerative Colitis: Research and Clinical Trials

Advancing Care of Crohn's Disease and Ulcerative Colitis Through Cutting-Edge Research

At the Mass General Crohn's and Colitis Center, we integrate outstanding clinical care with cutting-edge research to meet our patients’ needs and advance our understanding of these complex diseases. We believe that every patient can significantly contribute to our knowledge of Crohn's disease and ulcerative colitis, helping us understand their development, behavior, and response to treatments. Our physicians are actively researching the underlying causes of these diseases, aiming to develop more effective therapies and improve quality of life.

Patients interested in research can join our patient registries, enroll in clinical trials for new therapies, or participate in studies exploring dietary, lifestyle, and behavioral changes for managing these diseases.

Landmark Patient Registry Studies

We conduct pioneering patient registry studies that offer groundbreaking insights into Crohn’s disease and ulcerative colitis, particularly in understanding the role of genetics and the microbiome.

Patients can also choose to participate in our landmark study PRISM, which investigates the mechanisms behind these diseases. PRISM aims to identify markers in blood, stool, or biopsies that can predict disease progression, treatment response, and potential side effects. This information will help create more personalized care tailored to each individual patient's unique disease behavior. PRISM also explored how environmental factors such as diet and stress impact disease management and medication response.

Additionally, our center is involved in several multi-million dollar research initiatives funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This includes the Center for the Study of Inflammatory Bowel Disease (CSIBD), a collaborative effort involving various prestigious institutions. CSIBD focuses on unraveling the fundamental mechanisms of Crohn's disease and ulcerative colitis, covering areas like bacterial influences in the gut and genetic contributors.

To learn more or participate in these studies, please contact our research coordinator.

Cutting-Edge Clinical Trials of New Treatments

Our physicians are actively involved in clinical trials and research studies, aiming to bring promising new treatments for inflammatory bowel diseases as quickly as possible.

Below are some of the ongoing clinical trials for patients who may be not responding to their current treatments for Crohn’s disease or ulcerative colitis.

• Darvadstrocel (Cx601) for complex perianal fistulizing Crohn’s disease (Phase 3): Mass General is participating in an international trial investigating stem cell injections into fistulas to promote healing in Crohn’s patients with perianal fistulas.
• TAK-018 to prevent postoperative Crohn’s disease recurrence (Phase 2a): TAK-018 is a small molecule drug aimed at blocking gut bacteria that may trigger inflammation post-resection surgery in Crohn’s Disease patients.
• Filgotinib for moderate to severe Crohn’s disease (Phase 3): Filgotinib, a JAK1 inhibitor taken orally, is being studied in patients with Crohn’s disease that hasn’t responded to standard treatments in a multi-center trial.
• Risankizumab for moderate to severe ulcerative colitis (Phase 3): Risankizumab, an IL-23p9 inhibitor given via infusion or injection, is being evaluated for its efficacy in treating unresponsive ulcerative colitis in a phase 3 trial.

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Clinical Research and Trials for Patients

Our doctors are committed to conducting studies focused on addressing patient’s most critical needs that current research has not covered. We offer various ongoing research opportunities for patients interested in participating in studies that explore these important questions.

Diet and Microbiome Research

Our doctors are studying how diet and environment influences Crohn’s disease and ulcerative colitis development. Our physicians are leading clinical trials to explore the effectiveness of different diets in reducing inflammation. These studies also investigate how diet affects inflammation through the microbiome and explore potential microbiome-directed therapies, such as probiotics.

Study of Older Adults With IBD (LOGIC)

Our investigators have launched the LOGIC registry, one of New England’s first efforts focusing on understanding and addressing the unique challenges of treating IBD in older adults. The registry aims to evaluate the safety and effectiveness of various medical therapies and surgical interventions for this population.

Understanding Fatigue in IBD

Fatigue is a significant issue for nearly four in 10 patients with IBD, even when their disease is in remission. Our physicians are actively studying this issue and have made some key observations about how intestinal bacteria may impact energy levels. Ongoing clinical trials are examining the potential of certain probiotics to alleviate fatigue in patients with IBD.

The RIPPLE Study

The RIPPLE Study is dedicated to uncovering why some patients with Crohn’s disease and ulcerative colitis experience disease flares. Two ongoing studies are investigating how environmental factors, including diet, contribute to these flares. The studies also aim to identify changes in intestinal bacteria, blood, stool, and intestinal lining that trigger flares, with the goal of preventing relapses in patients who have achieved remission.

Microscopic Colitis Study and Registry

Our physicians are leading a study and registry focused on microscopic colitis, a specific type of IBD. This research aims to deepen our understanding of the condition’s development, leading to improved treatment and prevention strategies.

South Asian IBD Study

Crohn’s disease and ulcerative colitis have become prevalent global diseases. Our investigators are committed to finding better ways to prevent these diseases by studying populations where they are emerging, especially those of South Asian ancestry.

The ACTIVATED Study

While anti-TNF therapy has revolutionized IBD treatment, not all patients respond well to it, and immunosuppression can lead to side effects like infections and rare cancers. Therefore, safe non-immunosuppressive treatments are needed. This study aims to explore the potential of Vitamin D3 supplementation as an adjunct therapy for patients starting new anti-TNF therapy to see if it can boost the effectiveness of this treatment without adverse effects.