Health TrialsbyHealthPanel

Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation

ConditionRadiation Injuries
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Cincinnati

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pendulum Glucose Control (PGC)

    Biological/Vaccine

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: RT + ProbioticExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Week 6 and week 10

Secondary outcomes

1

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)
2

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cincinnati

Lead sponsor

Pendulum Therapeutics

Collaborator

Source ClinicalTrials.gov
Apply now