Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation
Part of paid clinical trials in Cincinnati, Ohio.
- Sponsor
- University of Cincinnati
- Study ID
- NCT07231588
- Phase
- EARLY_PHASE1
- Status
- Recruiting
Conditions
- Radiation Injuries
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pendulum Glucose Control (PGC) — BIOLOGICALPendulum Glucose Control (PGC) WBF-038 - 2 capsules Orally with food. Once daily for 10 weeks
Study Details
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 Dates
- Start date
- Jan 29, 2026
- Status verified
- Nov 2025
- Primary completion
- Jun 29, 2026
- Completion
- Dec 29, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: RT + ProbioticPendulum Glucose Control (PGC) probiotic + Radiation Therapy Treatment
Primary Outcome Measure
Pendulum Glucose Control (PGC) Probiotic Adherence Rate (PAR)- measured by pill counts [ Time Frame: Week 6 and week 10 ]
Central Contacts
- UCCC Clinical Trials Office513-584-7698
- Bailey Nelson, MD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | Bailey Nelson, MD (PRINCIPAL_INVESTIGATOR) |
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