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(SME-0734) Correlation Between IBD Exacerbation and Gut Microbiome Changes and Their Effect on Innate Immunity

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Inflammatory Bowel Disease Exacerbation and Changes in Gut Microbiome and Innate Immunity

Principal Investigator:
Saurabh Mehandru M.D.

Ralph M. Steinman M.D.
Daniel Mucida PhD
Luciano Marraffini PhD

Contact Information:
Clinical Research Support Office
The Rockefeller University
1230 York Avenue
New York, NY 10065
Telephone: 1-800-RUCARES
Enrollment Status:
Open to Enrollment

Brief Summary of Protocol:
The researchers at the Rockefeller University Hospitals are doing this research to understand how microbes (tiny organisms, bacteria) that are found in the stool and lining (mucosal membrane) of the lower part of the colon is different in individuals with stable and not stable inflammatory bowel disease (IBD) compared to healthy individuals.

IBD is a name given to a group of medical problems in which the lining of the intestines become red and swollen causing abdominal (stomach) pain and cramping, loose frequent stool (diarrhea), weight loss and loss of appetite. Two of the most common types of IBD are ulcerative colitis (UC) and Crohn’s disease. For this study, subjects with the UC form of IBD will be enrolled. The symptoms of UC can wax and wane (get worse and get better) in the intensity and severity of illness. When there is severe inflammation, the disease is considered to be in an “active stage”, and the person experiences a flare-up of the condition. When the degree of inflammation is less (or absent), the person usually is without symptoms, and the disease is considered to be in “remission”. Our study is designed to examine the natural setting of the microbes in your lower intestines (gut) and how they act in people with IBD in active stage disease, in those whose IBD is in remission and in healthy volunteers.

Detailed Description of Protocol:
About 50 people will take part in the research study at the Rockefeller University Hospital. Participation is about 13 months long and includes:
- 1 to 2 sigmoidoscopies
- Providing monthly stool samples for 12 months

The research study as a whole will last about 2 years.

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

- Confirmed diagnosis of Ulcerative Colitis
- Generally healthy



Children permitted to participate:

Potential Benefits.....
There is no direct benefit to you for taking part in this study. However, the information that we gain from this study may help others in the future.

Compensation is provided.