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Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients
study id #: NCT00248053
condition: Familial Adenomatous Polyposis
The purpose of this study is to assess if curcumin, a commonly used food spice, can regress colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited form of colorectal cancer.
intervention: Drug: curcumin
start date: November 2005
estimated completion: June 2008
last updated: September 20, 2012
phase of development: Phase 2
Intervention Model: Crossover Assignment
Masking: Open Label
- polyp number and size [ Time Frame:one year ]
- side effects and medication compliance [ Time Frame:one year ]
- Familial adenomatous polyposis
- 18 years of age or older
- 5 or more adenomas of colorectum or ileum
- Female patient of child bearing age not on effective birth control pills
- Pregnant women
- White blood cell (WBC) count less than 4000
- Platelets (Plts) less than 100,000
- Blood urea nitrogen (BUN) greater than 25
- Creatine greater than 1.5
- Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs) during duration of trial
- Patient with active bacterial infections of gastroesophageal reflux disease or peptic ulcer disease
- Patient on warfarin or anti-platelet drugs
sponsor: Johns Hopkins University
investigators: Francis M Giardiello, M.D.
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