Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy

Exclusion Criteria

• •1\. Patients receiving any type of immunotherapy including but not limited to immune checkpoint inhibitors that inhibit negative regulatory components of immune response such as cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) and the programmed cell death protein-1 and its ligand (PD1/ PDL1) and IL-2 cancer immunotherapy.
• •2\. Any cancer therapy for which antidiarrheal (antimotility) medications in the prophylaxis setting is mandatory, including but not limited to patients receiving neratinib and irinotecan.
• •3\. Ongoing irritable bowel syndrome (IBS) or colitis (including but not limited to ulcerative colitis, Crohn's disease, microscopic colitis, etc.).
• •4\. Ongoing diarrhea and/or diarrheal episodes within the previous 7 days prior to randomization into the study.
• •5\. Laxative use within 7 days prior to randomization or a history of constipation requiring the use of laxatives for more than ≥ 30 consecutive days.
• •6\. Inadequate organ function, which may include, but is not limited to, the following laboratory results within 28 days prior to signing consent: Total bilirubin \> upper limit of normal (ULN), AST (SGOT) and ALT (SPGT) \> 2.5 ULN (unless the participant has documented Gilbert's syndrome, hepatocellular carcinoma or hepatic metastases), serum creatinine \> 2.0 mg/dL or 177 μmol/L.
• •1. NOTE: Investigator discretion will determine continued eligibility after randomization occurs, in the event the liver function test results are greater than (\>) the proposed upper limit of normal.
• •7\. Use of other investigational drugs within 4 weeks of signed informed consent or foreseen use during the study.
• •8\. Use of antibiotics within the past 7 days (up to 2 prophylactic doses of antibiotic for procedures, including but not limited to port placement, is permitted) prior to randomization.
• •9\. Total colectomy and/or any type of gastrointestinal ostomy.
• •10\. Major abdominal or pelvic surgery within the past 3 months.
• •11\. Previous (within 1 month) or planned abdominal and/or pelvic radiation.
• •12\. Fecal incontinence from ongoing radiation-induced diarrhea or constipation
• •13\. Active systemic infection requiring ongoing intervention, including but not limited to oral and intravenous antibiotics, anti-fungals, anti-parasitics, and anti-viral drugs.
• •14\. Inability to comply with study requirements as judged by the Investigator.
• •15\. Pregnant and/or breastfeeding.