NCT07231588

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
8mo left

Started Jan 2026

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

November 12, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 29, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2026

Last Updated

February 5, 2026

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 12, 2025

Last Update Submit

February 2, 2026

Conditions

Radiation Injuries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Physician-reported GI toxicity with the addition of PGC - measured by CTCAE v6

    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

    Baseline, week 4, week 6 and week 10. Week 14 (safety visit)

Study Arms (1)

RT + Probiotic

EXPERIMENTAL

Pendulum Glucose Control (PGC) probiotic + Radiation Therapy Treatment

Biological: Pendulum Glucose Control (PGC)

Interventions

Pendulum Glucose Control (PGC)BIOLOGICAL

Pendulum Glucose Control (PGC) WBF-038 - 2 capsules Orally with food. Once daily for 10 weeks

RT + Probiotic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Age ≥18 years.
  • ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix A).
  • Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

  • Patients with inflammatory bowel disease (IBD - such as Crohn's or Ulcerative Colitis).
  • 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.
  • 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.
  • 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.
  • Patients who have received previous radiation therapy to the pelvis at any time.
  • Patients who have not recovered from GI adverse events due to previous cancer therapy.
  • Patients with colostomy or ileostomy.
  • Pregnant women are excluded from this study because they cannot receive radiotherapy.
  • Known inulin intolerance or allergies or hypersensitivity to any of the components of PGC, including:
  • Known hypersensitivity to \>4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: Penicillin, Piperacillin, Tetracycline, Amoxicillin, Ampicillin
  • Known hypersensitivity to \>4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26TM: Gentamicin, Kanamycin, Streptomycin, Tetracycline, Erythromycin, Clindamycin, Ampicillin, Vancomycin
  • Patients unable to swallow capsules.
  • Absolute Neutrophil Count (ANC) \< 1500/uL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

UCCC Clinical Trials Office

CONTACT

513-584-7698cancer@uchealth.com

Bailey Nelson, MD

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Open Label
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2025

First Posted

November 17, 2025

Study Start

January 29, 2026

Primary Completion (Estimated)

June 29, 2026

Study Completion (Estimated)

December 29, 2026

Last Updated

February 5, 2026

Record last verified: 2025-11

Locations

US(1)