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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 Crohn's disease: Actively recruiting
Crohn’s Disease/Ulcerative Colitis
Dietary therapy and gut microbiome in Inflammatory Bowel Disease – A clinical trial
The purpose of this study is to assess the role of two dietary therapies in Inflammatory Bowel Disease: enteral nutrition diet and specific carbohydrate diet. We aim to compare and assess the clinical effectiveness, biochemical improvement, as well as changes in intestinal microbiome composition and gene expression between the two dietary therapies.
Basic eligibility criteria:
Patients could qualify if they are at least 18 years old and have active IBD. Patients who have celiac disease, have indeterminate colitis, and/or have C. diff infection are excluded.
Ashwin Ananthakrishnan, MBBS, MPH
Christina Wong; 617-724-7559
Crohn’s Disease/Ulcerative Colitis/Indeterminate Colitis
Entyvio (vedolizumab) long-term safety study: An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn’s Disease (Entyvio PASS Study)
The purpose of this study aims to assess the long-term safety of vedolizumab vs. other biologic agents in patients with ulcerative colitis, Crohn’s disease, or indeterminate colitis. This study is non-interventional. The study uses disease activity scores, health resources, and patient reported quality of life assessments to assess changes in disease activity.
Patients could qualify if they are at least 18 years old and initiating vedolizumab or other biologic agent for ulcerative colitis or Crohn’s disease or indeterminate colitis. Patients who have had prior treatment with vedolizumab at study entry are excluded.
Genetic and Environmental Risks for Inflammatory Bowel Disease
The purpose of this study is to explore how IBD is inherited and why a given family member would or would not develop IBD. After consent, participation involves a short questionnaire, a single blood draw or saliva sample, and confirmation of diagnosis (for IBD patients only).
Patients with IBD: Must be at least 7 years of age with a diagnosis of either Crohn’s Disease or ulcerative colitis confirmed by medical record (clinic note, endoscopy or radiology report). Must be willing and able to provide a blood or saliva sample.
Healthy patients: Must be at least 18 years of age. Must be willing and able to provide a blood or saliva sample.
All patients must be a first-degree relative (parent, sibling, or child) of at least one other family member in the study.
Ramnik Xavier, MD, PhD
Thomas Cleland; 617-724-1619
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.
Keri Sullivan; 617-724-5955
Short Bowel Syndrome
A Prospective, Multi-center Registry for Patients with Short Bowel Syndrome
This study aims to collect and evaluate long-term safety profiles and clinical outcomes in patients with short bowel syndrome (SBS). This study is non-interventional.
Patients of any age with diagnosis of SBS can qualify. No exclusionary criteria.
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.
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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