Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation

Recruiting now · Early Phase 1

Conditions studied: Radiation Injuries

In brief

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.

Key facts

Study ID

NCT07231588

Run by

University of Cincinnati

People needed

20

Starts

2026-01-29

Expected to finish

2026-12-29

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Age ≥18 years.
• ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix A).
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• 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.

Where it is running

• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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