A multidisciplinary human study on the genetic, environmental and microbial interactions that cause inflammatory bowel disease — GEM Project

HS 2014-1466
Digestive Disease, Inflammatory Bowel Disease, Crohn’s disease, Ulcerative colitis
Nimisha Parekh, MD
Gottschalk Medical Center, Irvine/Hewitt Hall

The Genetic Environmental Microbial (GEM) Project is a prospective cohort research study, focusing on healthy siblings or offspring (aged 6 to 35 years old) of people diagnosed with Crohn’s disease. The objective is to collect a cohort of 5,000 of these high‐risk individuals. At this time another 2,200 are needed and will be recruited over the next 18 months. All subjects are followed for the development of Crohn’s disease. Our goal is to find the cause(s) or trigger(s) of Crohn’s disease, by determining why some first-degree relatives (FDR) develop the disease, while others do not. With this information, the development of new therapies for the treatment of Crohn’s disease may be possible, and even a cure may be found.

The GEM Project will focus on understanding and identifying the interactions between human genetics, environmental changes, and microbial changes that contribute to the development of Crohn’s disease. Each subject enrolled in the study will be asked to provide blood samples for genetic analysis, urine and stool samples, as well as answer a series of questions about their environmental exposures and dietary habits.

Probands (people who are affected by the disease)

  • Diagnosed as having Crohn’s disease by a treating physician
  • Must have a healthy sibling and/or offspring between 6 and 35 years of age
  • Are not pregnant (self-reported)

Subjects (siblings and offspring of people in the study)

  • Who are between 6 and 35 years of age,
  • Are not pregnant (self-reported)
  • Are “disease free”
  • Qualified siblings and/or offspring must be local

Proband: One hour long visit for the consenting process.

Subject (offspring or sibling of the proband): Two hours spread over two appointments.

Neither the proband nor subject will directly benefit from participation in this study. Their participation in this study may eventually provide the study doctors with valuable information about factors that lead to the development of Crohn’s disease. This could lead to improvements in the treatment of inflammatory bowel disease in the years to come.

Proband: Will not be compensated for this study.

Subject: May receive up to $150 for completing the study.

Douglas O'Connell, MS Gastroenterology