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Ongoing clinical trials for Crohn's disease: Actively recruiting


Condition:

Crohn’s Disease/Ulcerative Colitis

Study title:

Dietary therapy and gut microbiome in Inflammatory Bowel Disease – A clinical trial

Description of study:

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.

Principal Investigator:

Ashwin Ananthakrishnan, MBBS, MPH

Contact:

Christina Wong; 617-724-7559


Condition:

Crohn’s Disease/Ulcerative Colitis/Indeterminate Colitis

Study title:

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)

Description of 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.

Basic eligibility criteria:

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.

Principal Investigator:

Ashwin Ananthakrishnan, MBBS, MPH

Contact:

Christina Wong; 617-724-7559


Condition:

Crohn’s Disease/Ulcerative Colitis

Study title:

Genetic and Environmental Risks for Inflammatory Bowel Disease

Description of study:

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).

Basic eligibility criteria:

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.

Principal Investigator:

Ramnik Xavier, MD, PhD

Contact:

Thomas Cleland; 617-724-1619


Condition:

Crohn’s Disease/Ulcerative Colitis/Indeterminate Colitis

Study title:

PIANO: Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes: In Utero Exposure to Biologics and the Risk of Neonatal Infections

Description of study:

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.

Basic eligibility criteria:

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.

Principal Investigator:

Ashwin Ananthakrishnan, MBBS, MPH

Contact:

Keri Sullivan; 617-724-5955


Condition:

Short Bowel Syndrome

Study title:

A Prospective, Multi-center Registry for Patients with Short Bowel Syndrome

Description of study:

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.

Basic eligibility criteria:

Patients of any age with diagnosis of SBS can qualify. No exclusionary criteria.

Principal Investigator:

Ashwin Ananthakrishnan, MBBS, MPH

Contact:

Christina Wong; 617-724-7559


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:

Elizabeth Andrews; 617-724-2090


Condition:

Crohn’s Disease/Ulcerative Colitis/Indeterminate Colitis

Study title:

Serological and metabolomic correlates of fatigue in Inflammatory bowel diseases: A prospective cohort study

Description of 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.

Basic eligibility criteria:

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.

Principal Investigator:

Ashwin Ananthakrishnan, MBBS, MPH

Contact:

Nienke Borren, MD; 617-726-1997

 

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