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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 indeterminate colitis: Actively recruiting
Crohn’s Disease/Ulcerative Colitis/Indeterminate Colitis
A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease
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.
Deanna Nguyen, MD
Melissa Cohen; 617-724-3238
PIANO:Pregnancy inInflammatory Bowel DiseaseandNeonatalOutcomes
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.
Pregnant women with IBD who are enrolled in the National Registry study.
PIANO: Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes: In Utero Exposure to Biologics and the Risk of Neonatal Infections
The purpose of this study is to determine whether the rates of birth defects, miscarriages, premature births and other outcomes in women with inflammatory bowel disease (IBD) exposed to certain medications. In particular, we are interested in seeing if we can predict a risk of infection to the infant by looking at the level of the drug transferred across the placenta at birth.
Patients could qualify if they are at least 18 years old, are pregnant, have a confirmed IBD diagnosis (Crohn’s Disease/Ulcerative Colitis/Indeterminate Colitis) and are actively receiving treatment in the form of certain medications.
Ashwin Ananthakrishnan, MBBS, MPH
Keri Sullivan; 617-724-5955
Prospective Registry in IBD Study at MGH (PRISM)
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.
Exclusion criteria include inability or unwillingness to provide blood samples. Patients who have known bleeding disorders are also excluded from this group.
Ramnik Xavier, MD, PhD
Elizabeth Andrews; 617-724-2090
Serological and metabolomic correlates of fatigue in Inflammatory bowel diseases: A prospective cohort study
The purpose of this study is to identify why patients continue to experience significant fatigue despite their disease being in remission. We aim to examine the role of several biological markers as well as clinical factors that may be associated with fatigue.
Patients could qualify if they are at least 18 years old and have quiescent IBD. Fatigued and non-fatigued patients are eligible. Patients experiencing active disease or flare up are excluded.
Nienke Borren, MD; 617-726-1997
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