Radiation InjuriesEarly Phase 1NCT07231588
Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation
A Early Phase 1 study of Radiation Injuries, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Injuries
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2026to 29 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bailey Nelson, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
UCCC CTO, 513-584-7698, cancer@uchealth.com
Bailey Nelson, MD
About this study
Official title: Feasibility of an Oral 5 Strain Probiotic (PGC) for GI Toxicity Mitigation During Pelvic Radiation
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.
Read the 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
- Being tested
- Pendulum Glucose Control (PGC)
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pendulum Glucose Control (PGC)Biological
Pendulum Glucose Control (PGC) WBF-038 - 2 capsules Orally with food. Once daily for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| RT + Probiotic | Experimental | Pendulum Glucose Control (PGC) probiotic + Radiation Therapy Treatment Receives: Biological: Pendulum Glucose Control (PGC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pendulum Glucose Control (PGC) Probiotic Adherence Rate (PAR)- measured by pill counts
- To evaluate Pendulum Glucose Control (PGC) Probiotic Adherence Rate (PAR).
- To assess Probiotic Adherence Rate (PAR), pill counts will be conducted at week 6 and week 10.
Measured: Week 6 and week 10
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, week 4, week 6 and week 10. Week 14 (safety visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start29 Jan 2026
- Primary completion29 Jun 2026 (estimated)
- Study completion29 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation InjuriesStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Pendulum Therapeutics
- Responsible party
- Principal investigator, Bailey Nelson, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231588
- Sponsor's protocol ID
- UCCC-RT-25-02
- Status last verified
- Nov 2025
- First submitted
- 12 Nov 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Oral 5 Strain Probiotic (PGC) for GI Toxicity Mitigation During Pelvic Radiation
- ClinicalTrials.gov ID
- NCT07231588
- Acronym / sponsor ID
- UCCC-RT-25-02
- Conditions
- Radiation Injuries
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Pendulum Therapeutics
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 29 Jun 2026 (estimated)
- Study completion
- 29 Dec 2026 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| RT + Probiotic | Experimental | Biological: Pendulum Glucose Control (PGC)Pendulum Glucose Control (PGC) probiotic + Radiation Therapy Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pendulum Glucose Control (PGC)Pendulum Glucose Control (PGC) WBF-038 - 2 capsules Orally with food. Once daily for 10 weeks | Biological | RT + Probiotic |
Primary outcome
Pendulum Glucose Control (PGC) Probiotic Adherence Rate (PAR)- measured by pill counts
Time frame: Week 6 and week 10
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.
2 secondary outcomes
Physician-reported GI toxicity with the addition of PGC - measured by CTCAE v6
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
Time frame: Baseline, week 4, week 6 and week 10. Week 14 (safety visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bailey Nelson, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Radiation Injuries, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UCCC Clinical Trials Office (513-584-7698, cancer@uchealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pendulum Glucose Control (PGC) Probiotic Adherence Rate (PAR)- measured by pill counts (time frame: Week 6 and week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.