Trial Information

Summary: Procurement of blood samples for use in the development of gastrointestinal disease panel.

Women and Men, ages 18-70, are invited to participate in a research study conducted by Lin Chang, MD at the UCLA Center for Neurovisceral Sciences & Women's Health. The purpose of this study is to develop a diagnosis test for IBS and/or other gastrointestinal diseases.

General Subject Inclusion Criteria: These apply to all subjects.

• 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.

For normal controls (recruited at UCLA):
Inclusion Criteria:

• A normal healthy individual without repeated dyspepsia, abdominal pain, constipation or diarrhea within the last year. An occasional isolated instance of these symptoms is allowable.

For IBS These apply to all IBS subjects (recruited at UCLA).
Inclusion Criteria:

• The date of diagnosis of their disease by a GI specialist must be at least 1 year prior to study enrollment. (See appendix B for an example of how this might be documented in primary care practices.)
• Evidence in the medical chart that this diagnosis is based on continuous or repeated pain or discomfort that is improved by defecation.
• Symptoms must have occurred for at least 3 days each month in the last 3 months.

General Subject Exclusion Criteria: These apply to all subjects.

• A diagnosis of colorectal cancer.
• A diagnosis of diabetes (Type I or Type II).
• A diagnosis of HIV/AIDS or chronic viral hepatitis (HAV, HBV, or HCV).
• Use of anti-viral medications in the last month.
• Symptoms of an active ulcer or infection with Helicobacter pylori during the last 6 months.
• Viral or bacterial infection or disease in the 2 weeks preceding the date of sample collection.
• A diagnosis of an autoimmune disease such as rheumatoid arthritis, lupus, Parkinson's disease, multiple sclerosis, scleroderma, or autoimmune hepatitis.
• Confined to a wheel chair or bed. Subjects must be ambulatory and in good health except for their primary disease.
• Participation in an extreme sports event within the last month. (For example a marathon or triathlon, since these acutely change enzyme and metabolite levels.)
• Pregnancy or current breast feeding, or having given birth in the past 6 months.
• Use of any antibiotics in the past month (such as Rifaximin)
• Use of corticosteroids in the past 1 month, except for IBD subjects. They may take these medicines provided that they are prescribed as a treatment for their IBD.
• Cancer that required treatment in the last 3 years.
• Use of any investigational drug within the last 2 months.
• Evidence that the subject's GI symptoms are due to lactose intolerance or a food allergy. This criterion does not apply to the gluten intolerance of celiac subjects.
• Travel:
  • Normal controls, who must not be experiencing GI symptoms, may not have traveled outside the US or Canada in the last 1 month.
  • Disease category subjects, i.e. someone that has GI symptoms, may not have traveled outside of the US or Canada in the past 3 months.

Additional requirements for normal controls, IBS or other functional GI disease, IBD or celiac disease subjects are detailed in the disease-specific inclusion and exclusion criteria.

For normal controls (recruited at UCLA):
Exclusion Criteria:

• Use of any prescription anti-inflammatory drug in the last 2 weeks.
• Use of 600mg/day or greater of any over the counter nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen or naproxen 4 or more times per week in either of the last 2 weeks.
• A bacterial GI infection in the last month.
• Any active injury or process that results in an acute inflammation in the past 2 weeks. (For example a recent fracture or injury resulting in swollen joints.)
• A diagnosis of IBS, any other functional GI disease, IBD, microscopic colitis, or celiac disease.
• A first degree blood relative with a diagnosis of IBD, microscopic colitis or celiac disease.

Exclusion Criteria: These apply to all IBS subjects.

• Presence of "alarm signs" such as unintentional weight loss (more than 10 pounds in 3 months), frequent awakening by symptoms, fever, rectal bleeding or anemia.
• Evidence of any organic, infectious or structural cause of the GI disease.
• Use of any prescription anti-inflammatory drug in the last 2 weeks.
• Use of 600mg/day or greater of any over the counter nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen or naproxen 4 or more times per week in either of the last 2 weeks.
• Major abdominal surgery excluding an appendectomy, polyp removal or hiatal hernia repair.
• A diagnosis of any other functional GI disease, IBD, microscopic colitis, or celiac disease.
• A first degree blood relative with a diagnosis of IBD, microscopic colitis or celiac disease.

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Trial listings updated: September 9, 2008 at 3:33:04 PM