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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:

Elizabeth Andrews; 617-724-2090


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:

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:

Ulcerative Colitis

Study title:

Phase III, Double Blind, Placebo Controlled, Multicenter Study of the Efficacay and Safety of Ertolizumab During Induction and Maitenance in Patients with Moderate to Severe Active Ulcerative Colitis Who Are Refractory to or Intolerant of TNF Inhibitors (HICKORY)

Description of study:

This study aims to evaluate the safety, effectiveness, and tolerability of etrolizumab in inducing and maintaining clinical remission, compared to placebo, in patients with moderately to severely active ulcerative colitis.

Basic eligibility criteria:

Patients could qualify if they are between 18 to 80 years old and have moderately to severely active UC (as defined by the Mayo scoring system). Other inclusionary criteria include failure to respond or intolerance to no more than 2 anti-TNF inhibitors within 5 years, and washout of anti-TNF therapy for at least 8 weeks.

Exclusionary criteria include prior treatment with other anti-integrin agents (vedolizumab, natalizumab...etc), past or present fistula or abdominal abscess, and failure to meet laboratory values as outlined in the detailed protocol.

Principal Investigator:

Ashwin Ananthakrishnan, MBBS, MPH

Contact:

Christina Wong; 617-724-7559


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

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