| Exclusion Criteria: | 1) Histologically confirmed high-grade dysplasia.
2) Histologically confirmed diagnosis of invasive carcinoma of the esophagus.
3) Prior endoscopic therapy for Barrett's esophagus, including mucosal ablation, resection and esophagectomy, and photodynamic therapy.
4) History of esophageal strictures with moderate-to-severe dysphagia or odynophagia that may interfere with ingestion/swallowing of the study drug. Trial participation will be determined by the study investigator after consideration of other factors including severity of dysphagia and odynophagia, necessity for treatment of strictures, and nutritional status.
5) History of allergic reactions attributed to compounds of similar chemical or biologic composition to Poly E.
6) Participants may not be receiving any other investigational agents within 30 days prior to randomization or during the study.
7) Use of medications, herbs, and vitamin and mineral supplements that contain tea compounds should not be taken while participating in the study and on study drug and for 30 days prior to trial entry. If patients are consuming any of these items and would like to participate in this study, then a 30-day voluntary washout will be required.
8) Uncontrolled or significant co-morbid illness including, but not limited to, active or serious infection requiring intravenous antibiotics; symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia; active gastrointestinal bleeding; predisposing condition to gastrointestinal bleeding (including but not limited to gastritis, diverticulitis, colitis, and hemorrhoids); active malignancy diagnosed or treated within 5 years, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ,
9) Continued from # 8. Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy, Stage Ia Grade 1 adenomcarcinoma of the endometrium treated with surgery; patients receiving active chemotherapy or radiation; or psychiatric illness/social situations that would limit compliance with study requirements.
10) Participants will not take aspirin, aspirin-containing substances, coumadin (warfarin), heparin, or iron for 5 days before each endoscopy. |