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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Familial Adenomatous Polyposis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Lower GI

Group Type OTHER

curcumin

Intervention Type DRUG

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

Interventions

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curcumin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No