Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Radiation Injuries
• Intervention / Treatment: Biological: Pendulum Glucose Control (PGC)

Detailed Description

The exact mechanism of GI symptoms is elusive, but there is sufficient data to suggest that the intestinal microbiome plays a role in radiation-induced GI injury. The investigators propose a pilot feasibility trial evaluating whether an oral 5 strain probiotic (PGC) can be safely and effectively administered during pelvic RT. PGC will be supplied by Pendulum Therapeutics. Pendulum has completed trials using PGC in non-cancer conditions [26]. The investigators hypothesize that oral supplementation with PGC for GI toxicity mitigation during pelvic radiation is feasible. The intervention will be considered feasible if probiotic tolerability and patient adherence are appropriate. An overall probiotic adherence rate of ≥ 80% by ≥ 70% of patients will be considered acceptable. If feasible, these results will support evaluation of toxicity mitigation in randomized subsequent Phase II/III trials of PGC supplementation during pelvic radiation.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: UCCC Clinical Trials Office; Phone Number: 513-584-7698; Email: cancer@uchealth.com
• Study Contact Backup: Name: Bailey Nelson, MD

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University of Cincinnati Medical Center
      • Contact: UCCC CTO; Phone Number: 513-584-7698; Email: cancer@uchealth.com
      • Principal Investigator: Bailey Nelson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RT + Probiotic; Pendulum Glucose Control (PGC) probiotic + Radiation Therapy Treatment	Biological: Pendulum Glucose Control (PGC); Pendulum Glucose Control (PGC) WBF-038 - 2 capsules Orally with food. Once daily for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pendulum Glucose Control (PGC) Probiotic Adherence Rate (PAR)- measured by pill counts	1. To evaluate Pendulum Glucose Control (PGC) Probiotic Adherence Rate (PAR). a. To assess Probiotic Adherence Rate (PAR), pill counts will be conducted at week 6 and week 10.	Week 6 and week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician-reported GI toxicity with the addition of PGC - measured by CTCAE v6	To assess physician-reported GI toxicity, AEs using CTCAE v6 will be collected at baseline, week 4, week 6 and week 10. This will also be assessed at the 30 day safety visit after patients discontinue the supplement.	Baseline, week 4, week 6 and week 10. Week 14 (safety visit)
Patient-reported GI toxicity with the addition of PGC measured by PRO-CTCAE	To assess patient-reported GI toxicity, an EPIC Bowel and a customized PRO-CTCAE will be collected at baseline, week 4, week 6 and week 10. This will also be assessed at the 30 day safety visit after patients discontinue the supplement.	Baseline, week 4, week 6 and week 10. Week 14 (safety visit)

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Pendulum Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): June 29, 2026
• Study Completion (Estimated): December 29, 2026

Study Registration Dates

• First Submitted: November 12, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Radiation Injuries
• Other Study ID Numbers: UCCC-RT-25-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No