Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation
ConditionRadiation Injuries
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Cincinnati
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pendulum Glucose Control (PGC)
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Cincinnati
Lead sponsor
Pendulum Therapeutics
Collaborator
Source ClinicalTrials.gov