An Early Phase 1 interventional study of Pendulum Glucose Control (PGC) in Radiation Injuries, sponsored by University of Cincinnati. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by University of Cincinnati · Early Phase 1, Interventional, and Supportive care
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.
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.
108 studies on the registry are indexed under Radiation Injuries; 46 are open to participants now.
This study's planned enrollment of 20 is below the median of 68 across 66 interventional studies indexed under Radiation Injuries.
Browse Radiation Injuries studies →University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Known inulin intolerance or allergies or hypersensitivity to any of the components of PGC, including:
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
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.
Time frame: Week 6 and week 10
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.
Time frame: 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.
Time frame: Baseline, week 4, week 6 and week 10. Week 14 (safety visit)
Plan to share: Undecided
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