Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation

NCT ID: NCT07231588

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-29
• Study Completion Date: 2026-12-29

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.

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.

Conditions

Radiation Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

RT + Probiotic

Pendulum Glucose Control (PGC) probiotic + Radiation Therapy Treatment

Group Type: EXPERIMENTAL

Pendulum Glucose Control (PGC)

Intervention Type: BIOLOGICAL

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

Interventions

Pendulum Glucose Control (PGC)

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pendulum Therapeutics

INDUSTRY

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Bailey Nelson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

UCCC Clinical Trials Office

Role: CONTACT

cancer@uchealth.com

513-584-7698

Bailey Nelson, MD

Role: CONTACT

Facility Contacts

UCCC CTO

Role: primary

cancer@uchealth.com

513-584-7698

Other Identifiers

UCCC-RT-25-02

Identifier Type: -

Identifier Source: org_study_id