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Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation

RecruitingEARLY Phase 1Ages 18 Years - anyAllUniversity of Cincinnati
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In plain words

What the trial is, and whether it could suit you

This research is to determine if an oral probiotic, Pendulum Glucose Control (PGC), can be safely given to patients during pelvic radiation therapy (RT). The researchers will study if the probiotics lessen gastrointestinal toxicity during pelvic radiation.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Patients must have histologically confirmed malignancy for which the standard of care treatment is at least 30 Gy of pelvic RT to the pelvic lymph nodes. a. Eligible diagnoses include: i. Lower GI cancers (anal, rectal) ii. Gynecologic cancers (cervical, vulvar, vaginal, endometrial) iii. Prostate cancer with lymph node involvement 2. Age โ‰ฅ18 years. 3. ECOG performance status โ‰ค2 (or Karnofsky โ‰ฅ60%, see Appendix A). 4. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients with inflammatory bowel disease (IBD - such as Crohn's or Ulcerative Colitis). 2. 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. 3. 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. 4. 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. 5. Patients who have received previous radiation therapy to the pelvis at any time. 6. Patients who have not recovered from GI adverse events due to previous cancer therapy. 7. Patients with colostomy or ileostomy. 8. Pregnant women are excluded from this study because they cannot receive radiotherapy. 9. Known inulin intolerance or allergies or hypersensitivity to any of the components of PGC, including: 1. Known hypersensitivity to \>4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: Penicillin, Piperacillin, Tetracycline, Amoxicillin, Ampicillin 2. Known hypersensitivity to \>4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26TM: Gentamicin, Kanamycin, Streptomycin, Tetracycline, Erythromycin, Clindamycin, Ampicillin, Vancomycin 10. Patients unable to swallow capsules. 11. Absolute Neutrophil Count (ANC) \< 1500/uL.
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What it tests

  • Pendulum Glucose Control (PGC)
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Where

1 site
University of Cincinnati Medical Center
Cincinnati, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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