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

September 18, 2012 updated by: Francis M. Giardiello, Johns Hopkins University

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.

Study Overview

Status

Withdrawn

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lower GI
curcumin 500 mg by mouth, three times a day for 9 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
polyp number and size
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
side effects and medication compliance
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Francis M Giardiello, M.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 1, 2005

First Submitted That Met QC Criteria

November 1, 2005

First Posted (Estimate)

November 3, 2005

Study Record Updates

Last Update Posted (Estimate)

September 20, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

September 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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