Studie zur Vorbeugung von
Darmpolypen mit Grüntee-Extrakt

Inclusion & exclusion criteria

Interested persons are eligible for study participation if they are between 50-80 years of age, and have had histologically confirmed colorectal adenomas or serrated lesions removed during colonoscopy within the last 6 months. All participants of the study must be in good performance status at study entrance, corresponding to a level below 2 in the ECGG performance status scale [26]. Only patients able to give informed consent will be included after written informed consent.

Exclusion criteria for study participation are a history of hereditary nonpolyposis colorectal cancer (HNPCC) or familial adenomatous polyposis (FAP), a history of colorectal cancer or other concomitant cancers with the exception of basal cell carcinoma or curative treated cancers without actual anticancer medication. In addition, interested parties with intestinal malabsorption, short bowel syndrome or surgical bowel interventions leading to malabsorption will not be included into the study. Liver failure (hepatitis, cirrhosis), elevation of the liver enzymes ALT, AST or bilirubin to more than 2.5-fold above the upper normal value or inflammatory bowel disease are also exclusion criteria.

Regular intake of NSAIDs (including Cox-2 inhibitors) for more than 3 months per year, with the exception of low-dose ASS (≤ 100 mg per day), is not compatible with study participation. In addition, individuals who are on immunosuppressive medication are excluded from the study.

Individuals with impaired capacity to consent or who are impaired in swallowing pills will not be eligible for study participation.

In addition, subjects who have regularly consumed green tea extract with an EGCG content of more than 100 mg per day as a nutritional supplement for more than six months during the past two years will be excluded, as will individuals who have shown allergic reactions to green tea or its extract.

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