Back to full list of clinical trials

Ongoing clinical trials for indeterminate colitis: Actively recruiting


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 inInflammatory Bowel DiseaseandNeonatalOutcomes

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:

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:

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

Back to Top