Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation (NCT07231588) | Clinical Trial Compass
RecruitingEarly Phase 1
Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation
United States20 participantsStarted 2026-01-29
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. 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.
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What they're measuring
1
Pendulum Glucose Control (PGC) Probiotic Adherence Rate (PAR)- measured by pill counts