Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation

Exclusion Criteria13

• Patients with inflammatory bowel disease (IBD - such as Crohn's or Ulcerative Colitis).
• Patients who are currently receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.
• Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous, in the opinion of the Investigator.
• Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the Investigator.
• Patients who have received previous radiation therapy to the pelvis at any time.
• Patients who have not recovered from GI adverse events due to previous cancer therapy.
• Patients with colostomy or ileostomy.
• Pregnant women are excluded from this study because they cannot receive radiotherapy.
• Known inulin intolerance or allergies or hypersensitivity to any of the components of PGC, including:
• Known hypersensitivity to \>4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: Penicillin, Piperacillin, Tetracycline, Amoxicillin, Ampicillin
• Known hypersensitivity to \>4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26TM: Gentamicin, Kanamycin, Streptomycin, Tetracycline, Erythromycin, Clindamycin, Ampicillin, Vancomycin
• Patients unable to swallow capsules.
• Absolute Neutrophil Count (ANC) \< 1500/uL.