Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy

Inclusion Criteria:

1. Patients to receive targeted cancer therapy drugs that have a reported an allgrade diarrhea incidence of 50% or higher (e.g., tyrosine kinase inhibitors,cdk inhibitors, anti-EGFR, etc., for treatment of solid tumors.

2. Patients able to provide written informed consent.

3. Men and women ≥ 18 years of age.

4. Pathologically and/or radiologically confirmed diagnosis of solid tumorsscheduled to receive targeted cancer therapy.

5. Patients eligible to receive targeted cancer therapy per NCCN (NationalComprehensive Cancer Network) guidelines and/or standard-of-care practice, withor without cycle chemotherapy.

6. Patient can receive concomitant cycle [standard] chemotherapy agents togetherwith their targeted cancer therapy treatment regimens.

7. ECOG (Eastern Cooperative Oncology Group) performance status 0-2 and expectedto survive a 12-week course of targeted therapy with or without chemotherapy

8. Negative urine pregnancy test at time of informed consent for women ofchildbearing potential.

Exclusion Criteria:

1. Patients receiving any type of immunotherapy including but not limited toimmune checkpoint inhibitors that inhibit negative regulatory components ofimmune 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-2cancer immunotherapy.

2. Any cancer therapy for which antidiarrheal (antimotility) medications in theprophylaxis setting is mandatory, including but not limited to patientsreceiving neratinib and irinotecan.

3. Ongoing irritable bowel syndrome (IBS) or colitis (including but not limited toulcerative colitis, Crohn's disease, microscopic colitis, etc.).

4. Ongoing diarrhea and/or diarrheal episodes within the previous 7 days prior torandomization into the study.

5. Laxative use within 7 days prior to randomization or a history of constipationrequiring the use of laxatives for more than ≥ 30 consecutive days.

6. Inadequate organ function, which may include, but is not limited to, thefollowing laboratory results within 28 days prior to signing consent: Totalbilirubin > upper limit of normal (ULN), AST (SGOT) and ALT (SPGT) > 2.5 ULN (unless the participant has documented Gilbert's syndrome, hepatocellularcarcinoma or hepatic metastases), serum creatinine > 2.0 mg/dL or 177 μmol/L.

7. NOTE: Investigator discretion will determine continued eligibility afterrandomization occurs, in the event the liver function test results are greaterthan (>) the proposed upper limit of normal.

8. Use of other investigational drugs within 4 weeks of signed informedconsent or foreseen use during the study.

9. Use of antibiotics within the past 7 days (up to 2 prophylactic doses ofantibiotic for procedures, including but not limited to port placement, ispermitted) prior to randomization.

10. Total colectomy and/or any type of gastrointestinal ostomy.

11. Major abdominal or pelvic surgery within the past 3 months.

12. Previous (within 1 month) or planned abdominal and/or pelvic radiation.

13. Fecal incontinence from ongoing radiation-induced diarrhea or constipation

14. Active systemic infection requiring ongoing intervention, including butnot limited to oral and intravenous antibiotics, anti-fungals,anti-parasitics, and anti-viral drugs.

15. Inability to comply with study requirements as judged by the Investigator.

16. Pregnant and/or breastfeeding.