Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients

study id #: NCT00248053

condition: Familial Adenomatous Polyposis

status: withdrawn

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

study design:
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label

primary outcomes:

• polyp number and size [ Time Frame:one year ]

secondary outcomes:

• side effects and medication compliance [ Time Frame:one year ]

inclusion criteria:

exclusion criteria:
- 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
- Malignancy
- 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.