Actively Recruiting
Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation
Led by University of Cincinnati · Updated on 2026-02-05
20
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
U
University of Cincinnati
Lead Sponsor
P
Pendulum Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically confirmed malignancy requiring at least 30 Gy of pelvic radiation therapy to pelvic lymph nodes
- Eligible cancers include lower GI cancers (anal, rectal), gynecologic cancers (cervical, vulvar, vaginal, endometrial), and prostate cancer with lymph node involvement
- Age 18 years or older
- ECOG performance status 2 or less (or Karnofsky score 60% or higher)
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Inflammatory bowel disease such as Crohn's or ulcerative colitis
- Currently receiving other investigational agents (prior investigational agents may be allowed at PI discretion)
- Uncontrolled illnesses or conditions that make participation unsafe
- Prior or concurrent malignancies that may interfere with safety or efficacy assessment
- Previous pelvic radiation therapy
- Not recovered from gastrointestinal adverse events from prior cancer therapy
- Presence of colostomy or ileostomy
- Pregnancy (due to inability to receive radiotherapy)
- Known intolerance or allergies to components of PGC probiotic or related antimicrobial therapies
- Unable to swallow capsules
- Absolute neutrophil count below 1500/uL
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
U
UCCC Clinical Trials Office
CONTACT
B
Bailey Nelson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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