Oral 5‑strain probiotic to reduce bowel side effects during pelvic radiation

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

This pilot will try giving an oral 5‑strain probiotic (Pendulum Glucose Control) to adults receiving pelvic radiation to see if it safely reduces gastrointestinal side effects.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Cincinnati (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT07231588 on ClinicalTrials.gov

What this trial studies

This is an early‑phase pilot feasibility trial testing whether oral supplementation with a 5‑strain probiotic (PGC) can be safely given during pelvic radiation therapy and whether patients will adhere to the regimen. Adults with pelvic malignancies receiving at least 30 Gy to pelvic nodes (including lower GI, gynecologic, and node‑positive prostate cancers) are eligible if they meet performance status and other criteria. The study will measure tolerability and adherence, with a predefined feasibility threshold of ≥80% adherence in ≥70% of participants, and will monitor gastrointestinal toxicity during radiotherapy. If feasible, the results will support larger randomized trials to test whether PGC reduces radiation‑related GI injury.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed lower GI, gynecologic, or node‑positive prostate cancers scheduled for at least 30 Gy pelvic radiotherapy, ECOG ≤2, willing to consent and able to attend the University of Cincinnati visits.

Not a fit: Patients with inflammatory bowel disease, uncontrolled intercurrent illness, or those receiving other investigational agents may be excluded or unlikely to benefit from this probiotic intervention.

Why it matters

Potential benefit: If successful, patients could experience fewer or less severe radiation‑related bowel symptoms during and after pelvic radiotherapy.

How similar studies have performed: Pendulum Therapeutics has completed trials of PGC in non‑cancer conditions, but using this probiotic specifically during pelvic radiation is a novel and largely untested approach.

Eligibility criteria

Inclusion Criteria:

1. 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.

   a. Eligible diagnoses include: i. Lower GI cancers (anal, rectal) ii. Gynecologic cancers (cervical, vulvar, vaginal, endometrial) iii. Prostate cancer with lymph node involvement
2. Age ≥18 years.
3. ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix A).
4. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients with inflammatory bowel disease (IBD - such as Crohn's or Ulcerative Colitis).
2. 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.
3. 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.
4. 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.
5. Patients who have received previous radiation therapy to the pelvis at any time.
6. Patients who have not recovered from GI adverse events due to previous cancer therapy.
7. Patients with colostomy or ileostomy.
8. Pregnant women are excluded from this study because they cannot receive radiotherapy.
9. Known inulin intolerance or allergies or hypersensitivity to any of the components of PGC, including:

   1. Known hypersensitivity to \>4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: Penicillin, Piperacillin, Tetracycline, Amoxicillin, Ampicillin
   2. Known hypersensitivity to \>4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26TM: Gentamicin, Kanamycin, Streptomycin, Tetracycline, Erythromycin, Clindamycin, Ampicillin, Vancomycin
10. Patients unable to swallow capsules.
11. Absolute Neutrophil Count (ANC) \< 1500/uL.

Where this trial is running

Cincinnati, Ohio

• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: UCCC Clinical Trials Office

Conditions Radiation Injuries