Prometheus Laboratories: Procurement of blood samples for use in the development of a gastrointestinal disease test panel

IRB #: HUM00015569
Principal Investigator: William Chey, MD
Study Coordinator: Lina, Tel: 734.936.2761, lnahlawi@med.umich.edu

Study Objective:
The objective of this study is to develop a panel of biomarkers that will assist the physician in making a diagnosis of IBS or other functional GI disorders.  Serum and plasma markers will be evaluated in samples from normal controls, subjects with known IBS, subjects with functional GI disease, subjects with IBD and subjects with celiac disease.

Study Design:
Approximately 1900 subjects enrolled at approximately 50 sites within the USA.  Approximately 30 subjects will be enrolled at UM.  The majority of subjects will be in the study for one or two doctor’s office visits.  The subject will complete the questionnaire, and will give up to 30 ml non-fasting blood sample.

Subject Eligibility:

• Adults between 18 -70 years of age.
• All subjects age 50 yrs or older must have had a colonoscopy with no evidence of colon cancer.  All findings must be consistent with the subject’s disease or normal control status.
• No history of colorectal cancer.
• Must not have diabetes (Type I or Type II).
• Must not have a diagnosis of HIV/AIDS or chronic viral hepatitis (HAV, HBV, or HCV).
• Must not have symptoms of an active ulcer or infection with Helicobacter pylori during the last 6 months.
• Must not have a viral or bacterial infection or disease in the 2 weeks preceding the date of sample collection.
• Must not have a diagnosis of an autoimmune disease such as rheumatoid arthritis, lupus, Parkinson’s disease, multiple sclerosis, scleroderma, or autoimmune hepatitis.
• Must not have used any antibiotics in the past month

Compensation:  $30