Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis (FAP) Patients
Phase 2
18 Years
85 Years
18 Years
85 Years
Not Enrolling
Both
Familial Adenomatous Polyposis
Both
Familial Adenomatous Polyposis
Trial Information
Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis (FAP) Patients
Inclusion Criteria:
- Familial adenomatous polyposis
- 18 years of age or older
- 5 or more adenomas of colorectum or ileum
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Outcome Measure:
polyp number and size
Outcome Time Frame:
one year
Principal Investigator
Francis M Giardiello, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Johns Hopkins University
Authority:
United States: Institutional Review Board
Study ID:
05-04-12-04
NCT ID:
NCT00248053
Start Date:
November 2005
Completion Date:
Related Keywords:
- Familial Adenomatous Polyposis
- Familial adenomatous polyposis patient with 5 or more adenomatous polyps in the colon or ileoanal pouch
- Adenomatous Polyposis Coli
- Colorectal Neoplasms
- Nasopharyngeal Neoplasms
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