Trial Information

Effects of the Dietary Supplementation With a Blend of ER Beta Agonists on the Expression of ER Beta and Related Biomarkers of Cell Proliferation and Apoptosis, in Sporadic Colon Adenopolyposis

Enrolled patients were actively ongoing the surveillance program for the follow up of polyp
recurrence and progression to CRC. Eligible patients should have undergone a polypectomy
since 2003, affected by multiple polyps < 10 mm or one-two adenomas < 10 mm and/or with a
grade of dysplasia to make them classified at intermediate risk for CRC, and scheduled to
screening colonoscopy each 3-5 years. Patients were sequentially 1:1 randomly allocated to
placebo or Eviendep at baseline (T0). The dietary supplements were administered twice a day
for 60 days in advance of the screening colonoscopy, thus covering approximately eight
complete colon epithelial turnover to occur. Five days in advance of T60 colonoscopy,
patients refrained from fresh and cooked fruit and vegetable intake. Bowel cleansing was
achieved by PEG 4000 oral administration (1120 g/4 L water solution). N=8 biopsy
samples/patient were collected from the non adenomatous mucosa in the sigmoidal colon. Small
polyps (diameter less or equal 0.5 cm) were topically electrocoagulated, whereas villous and
tubulovillous polyps (diameter equal or higher than 0.5 cm) were submitted to the
histological assessment.