Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer

Prior treatment

• Has taken linaclotide within 30 days prior to consent
• Participants may not be receiving any other investigational agents, or be active participants in any clinical trials. If participants previously participated in a clinical trial, a 30 day washout period for the investigational drug is needed before the participant can be considered for this study
• History of bleeding/coagulation problems. Concurrent use of nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin is acceptable

Other illness

• History of gastroparesis
• History of celiac disease
• Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
• Any malignancy except colorectal cancer or any active radiotherapy or cytotoxic chemotherapy within the last 6 months of baseline. Participants with a history of basal cell or squamous cell skin cancer may be enrolled at the discretion of the investigator
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to linaclotide
• Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Any medical condition judged by the investigator to constitute a risk to safe participation

Lab values

• Chronic use of anti-coagulants or non-NSAID anti-platelet agents will serve as an exclusion only when such medications cannot be safely discontinued before study related endoscopy or surgery

Other

• Microscopic colitis, including collagenous colitis
• Pregnant or lactating women
• At risk for obstructing or near-obstructing mechanical gastrointestinal obstruction

• History of 1 or more sporadic colorectal adenoma on previous endoscopy (adenoma cohort) or stage 0-3 biopsy proven colorectal cancer (CRC) (colorectal cancer cohort) who are scheduled for a surgical procedure
• Ability to understand and willingness to sign a written informed consent document and follow study procedures
• Ability to swallow capsules without difficulty
• Ability to maintain pill diaries
• Willingness to employ adequate contraception for men and women of childbearing potential for the duration of the study. Acceptable methods include double barrier methods, intrauterine device (IUD), postmenopausal status, and/or documentation of surgical sterilization
• Participants must have no chronic, clinically severe health issues which, in the opinion of their physician or the research team, could preclude trial activities including the one week drug exposure phase