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

Phase 2

Withdrawn

• Conditions: Familial Adenomatous Polyposis
• Interventions: Drug: curcumin

• Registration Number: NCT00248053
• Lead Sponsor: Johns Hopkins University

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 available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-01
• Study First Submitted QC: 2005-11-01
• Study First Posted: 2005-11-03
• Primary Completion: 2008-06
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-18
• Last Update Posted: 2012-09-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lower GI	curcumin	-

Primary Outcome Measures

Name	Time	Method
polyp number and size	one year

Secondary Outcome Measures

Name	Time	Method
side effects and medication compliance	one year