The mission of our clinical research is to foster discoveries in the novel therapies of inflammatory bowel diseases, gastrointestinal and pancreatic cancer, hepatitis, and other gastrointestinal disorders. Our doctors are committed to providing the best care and management of diseases while testing cutting-edge therapies.

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Ongoing clinical trials for ulcerative colitis: Actively recruiting


Condition:

Crohn’s Disease/Ulcerative Colitis/Indeterminate Colitis

Study title:

Prospective Registry in IBD Study at MGH (PRISM)

Description of study:

The purpose of the study is to increase understanding about the causes of inflammatory bowel disease (IBD) as well as the factors that may influence the course of IBD over time.

Basic eligibility criteria:

Exclusion criteria include inability or unwillingness to provide blood samples.  Patients who have known bleeding disorders are also excluded from this group.

Principal Investigator:

Ramnik Xavier, MD, PhD

Contact:

Holly Sturgeon; 617-724-7559


Condition:

Crohn’s Disease/Ulcerative Colitis/Indeterminate Colitis

Study title:

A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease

Description of study:

The purpose of this research study is to determine whether the rates of birth defects, miscarriages, premature births and other outcomes in women with inflammatory bowel disease exposed to certain medications or anti-TNF therapy are greater than those among IBD-affected women not taking these medications.  This information will be valuable in guiding therapy of women with IBD who wish to have children while receiving this therapy for their illness. 

Basic eligibility criteria:

Pregnant women with IBD who are exposed to immunomodulators or biologics.  Women with multiple gestations are excluded.  

Principal Investigator:

Deanna Nguyen, MD

Contact:

Melissa Cohen; 617-724-3238


Condition:

Crohn’s Disease/Ulcerative Colitis/Indeterminate Colitis

Study title:

PIANO: Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes

Description of study:

This research study is being done to determine whether the achievement of developmental milestones, rates of growth by height and weight, and protection against infections are reduced in the children of women with IBD.  The role of medications used during pregnancy on these outcomes will also be studied. 

Basic eligibility criteria:

Pregnant women with IBD who are enrolled in the National Registry study. 

Principal Investigator:

Deanna Nguyen, MD

Contact:

Melissa Cohen; 617-724-3238


Condition:

Ulcerative Colitis

Study title:

Randomized, Double Blind, Prospective Trial Investigating the Efficacy of Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis (MEthotrexate Response In Treatment of UC - MERIT-UC)

Description of study:

This study aims to evaluate the effectiveness of methotrexate (MTX) applied subcutaneously once weekly in the induction and maintenance of steroid free remission or response in patients with steroid dependent ulcerative colitis or UC that has failed to respond to or is intolerant to anti-TNF therapy, azathioprine or 6-mercaptopurine (6-MP) compared to placebo.

Basic eligibility criteria:

Patients would qualify for the study if they are between the ages of 18 and 70 and currently have active UC (as defined by the Mayo scoring system). In addition, patients must be steroid dependent or have disease which is refractory to infliximab or azathiproine/6MP.

Exclusionary criteria include failure to respond to high dose prednisone in the two weeks preceding inclusion in the study, failure to adequately wash-out of prohibited medications (anti-TNF therapy, azathioprine, 6-MP), failure of cyclosporine therapy in the previous 6 months, underlying infection (including C. difficile infection) at baseline, and abnormal laboratory values as outline in the detailed protocol.

Principal Investigator:

Vijay Yajnik, MD, PhD

Contact:

Melissa Cohen; 617-724-3238