Feasibility of an Oral 5 Strain Probiotic (PGC) for GI Toxicity Mitigation During Pelvic Radiation

What this Trial Is About

Researchers are evaluating the safety and feasibility of an oral probiotic called Pendulum Glucose Control (PGC) in patients undergoing pelvic radiation therapy (RT). This early-phase trial aims to see if PGC can reduce gastrointestinal (GI) toxicity caused by radiation, as the intestinal microbiome may play a role in radiation-induced GI injury. The study will assess probiotic tolerability and patient adherence to treatment to determine if further trials are warranted. Participants will take two capsules of PGC daily with food for 10 weeks while receiving pelvic RT. The probiotic contains five strains and is supplied by Pendulum Therapeutics. The study considers adherence acceptable if at least 70% of patients maintain an overall probiotic adherence rate of 80% or higher. The treatment period includes close monitoring during and after radiation therapy. Throughout the study, researchers will measure adherence by counting pills at weeks 6 and 10. They will also evaluate GI toxicity using both physician reports and patient questionnaires at baseline, week 4, week 6, week 10, and a safety visit at week 14. Participants will be monitored for any adverse events, and their overall health status will be assessed during this time. The study is sponsored by the University of Cincinnati and is planned to run until late 2026.

Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation