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This study has been withdrawn prior to enrollment.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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 2005

Last Updated Date

September 18, 2012

Start Date ^ICMJE

November 2005

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

polyp number and size [ Time Frame: one year ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00248053 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Familial Adenomatous Polyposis

Intervention ^ICMJE

Drug: curcumin

curcumin 500 mg by mouth, three times a day for 9 months

Study Arm (s)

Lower GI

Intervention: Drug: curcumin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00248053

Other Study ID Numbers ^ICMJE

05-04-12-04

Has Data Monitoring Committee

Responsible Party

Francis M. Giardiello, Johns Hopkins University

Study Sponsor ^ICMJE

Johns Hopkins University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Francis M Giardiello, M.D.

Johns Hopkins University

Information Provided By

Johns Hopkins University

Verification Date

September 2012

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

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