Studie zur Vorbeugung von
Darmpolypen mit Grüntee-Extrakt

Study visits

Every four months during the 36 months of the whole study, the participants will be asked to visit the gastroenterological centers to check for any adverse events and medication changes, and to confirm with the physician the regular intake of the study medication. Blood sampling for liver enzyme testing will be performed after run in, and at the 4, 12, 20 and 36 month visits, and at 4, 20 and 36 months for biomarker sampling.

Data on health status, medication, and complaints about the study substance will be collected and the study diary will be reviewed. After each clinical visit, the study medication for the next study period will be dispensed. In cases of non-compliance or any disruption longer than four months of intake of EGCG, the study investigators will decide whether the participant may continue in the study.

The final study visit will be for the control colonoscopy three years after the start of the study. If additional colonoscopies have been performed during the three year interval, the results of those will be documented as well. The results of the colonoscopy as well as the histological confirmation of potential metachronous colorectal adenomas will be documented, as well as clinical data on medication, health status, complaints and adherence to capsule intake.

Follow-up visits are planned for three and six years after the end of the study in order to assess the long term development of adenomas since we know that it may take years to see the effect of a preventive treatment. As an example, the effect of ASS chemoprevention on colon carcinoma was assessed 10 years after [33].

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