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) — BIOLOGICAL
    Pendulum 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 + Probiotic
    Pendulum 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Cincinnati Medical CenterCincinnatiOhio45219
UCCC CTO
513-584-7698
Bailey Nelson, MD (PRINCIPAL_INVESTIGATOR)

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