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

Familial Adenomatous Polyposis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00248053
• Other study ID #: 05-04-12-04
• Status: Withdrawn
• Phase: Phase 2
• First received: November 1, 2005
• Last updated: September 18, 2012
• Start date: November 2005

Study information

• Verified date: September 2012
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Familial Adenomatous Polyposis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	polyp number and size		one year
Secondary	side effects and medication compliance		one year