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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Cincinnati Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: UCCC Clinical Trials Office
• Email: cancer@uchealth.com
• Phone: 513-584-7698

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.