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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00248053
Recruitment Status : Withdrawn (Subsequent data generated by our collaborators have shown efficacy with curcumin and quercetin in 5 patients in a non placebo controlled trial.)
First Posted : November 3, 2005
Last Update Posted : September 20, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Familial Adenomatous Polyposis Drug: curcumin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis (FAP) Patients
Study Start Date : November 2005
Primary Completion Date : June 2008


Arms and Interventions

Arm Intervention/treatment
Lower GI Drug: curcumin
curcumin 500 mg by mouth, three times a day for 9 months


Outcome Measures

Primary Outcome Measures :
  1. polyp number and size [ Time Frame: one year ]

Secondary Outcome Measures :
  1. side effects and medication compliance [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248053


Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Francis M Giardiello, M.D. Johns Hopkins University
More Information

Responsible Party: Francis M. Giardiello, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00248053     History of Changes
Other Study ID Numbers: 05-04-12-04
First Posted: November 3, 2005    Key Record Dates
Last Update Posted: September 20, 2012
Last Verified: September 2012

Keywords provided by Francis M. Giardiello, Johns Hopkins University:
Familial adenomatous polyposis patient with 5 or more adenomatous polyps in the colon or ileoanal pouch

Additional relevant MeSH terms:
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyposis Coli
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic