Recruiting
Early Phase 1

Pendulum Glucose Control

Sponsor:

University of Cincinnati

Code:

NCT07231588

Conditions

Radiation Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pendulum Glucose Control (PGC)

Study Details

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.

Conditions

Radiation Injuries

Study ID

NCT07231588

Start date

Jan 29, 2026

Status verified date

Nov, 2025

Completion date

Dec 29, 2026

Anticipated

Primary completion date

Jun 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: RT + Probiotic

Pendulum Glucose Control (PGC) probiotic + Radiation Therapy Treatment

Interventions

Pendulum Glucose Control (PGC)

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

Primary outcome measure

  • Pendulum Glucose Control (PGC) Probiotic Adherence Rate (PAR)- measured by pill counts [ Time Frame: Week 6 and week 10 ]

Central Contacts and Locations

Central contacts

UCCC Clinical Trials Office

513-584-7698cancer@uchealth.com

Locations

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

Bailey Nelson, MD

More Information

Sponsor

University of Cincinnati

Last update posted

Feb 5, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-02-05.