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

NCT ID: NCT00248053

Last Updated: 2012-09-20

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WITHDRAWN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.

Detailed Description

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Conditions

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Familial Adenomatous Polyposis

Keywords

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Familial adenomatous polyposis patient with 5 or more adenomatous polyps in the colon or ileoanal pouch

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

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Francis M. Giardiello

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francis M Giardiello, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Countries

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United States

Other Identifiers

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05-04-12-04

Identifier Type: -

Identifier Source: org_study_id