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Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride

Colorectal Adenomas Clinical Trial

Official title:
The Effect of Berberine Hydrochloride in Familial Adenomatous Polyposis:a Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter Clinical Trial

Clinical Trial Summary

In recent years, Berberine hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic towards cancer cells. Patients with familial adenomatous polyposis have a nearly 100 percent risk of colorectal cancer. The aim of this study is to investigate the chemopreventive effects Berberine hydrochlorid on the regression of colorectal adenomas.

Clinical Trial Description

Familial adenomatous polyposis is an autosomal dominant syndrome caused by a germ-line mutation of the adenomatous polyposis coli (APC) gene located at chromosome 5q21. The disorder is characterized by the development of hundreds of colorectal adenomas during adolescence. Colorectal cancer will develop in nearly all affected persons by the sixth decade of life if prophylactic colectomy is not performed. Because the adenoma-to-carcinoma sequence in familial adenomatous polyposis resembles sporadic colon carcinogenesis, studies of familial adenomatous polyposis may contribute to the prevention of sporadic adenomas and colon cancer. BBR, an isoquinoline alkaloid, is a natural compound in numerous Chinese herb plants such as Berberisaristata, Coptischinensis, Coptis rhizome, etc. In recent years, Berberine hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic towards cancer cells. The aim of this study is to investigate the regression effect of Berberine hydrochloride on the colorectal adenomas in patients with familial adenomatous polyposis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03333265
Study type Interventional
Source Xijing Hospital of Digestive Diseases
Contact
Status Completed
Phase Phase 2/Phase 3
Start date September 1, 2017
Completion date June 1, 2021
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