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

This study has been withdrawn prior to enrollment.
(Subsequent data generated by our collaborators have shown efficacy with curcumin and quercetin in 5 patients in a non placebo controlled trial.)
Sponsor:
Information provided by (Responsible Party):
Francis M. Giardiello, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00248053
First received: November 1, 2005
Last updated: September 18, 2012
Last verified: September 2012

November 1, 2005
September 18, 2012
November 2005
June 2008   (final data collection date for primary outcome measure)
polyp number and size [ Time Frame: one year ]
Not Provided
Complete list of historical versions of study NCT00248053 on ClinicalTrials.gov Archive Site
side effects and medication compliance [ Time Frame: one year ]
Not Provided
Not Provided
Not Provided
 
Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients
Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis (FAP) Patients

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Familial Adenomatous Polyposis
Drug: curcumin
curcumin 500 mg by mouth, three times a day for 9 months
Lower GI
Intervention: Drug: curcumin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00248053
05-04-12-04
No
Francis M. Giardiello, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Francis M Giardiello, M.D. Johns Hopkins University
Johns Hopkins University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP