Could a probiotic pill protect your gut during cancer radiation?
NCT ID NCT07231588
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a daily probiotic pill (Pendulum Glucose Control) can safely reduce stomach and bowel problems in people receiving radiation for cancers of the pelvis, such as prostate, gynecologic, or lower GI cancers. About 20 adults will take the probiotic during their radiation treatment, and researchers will track how well they stick with the pills and any side effects. The goal is to see if this simple addition can make treatment easier to tolerate.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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University of Cincinnati Medical Center
RECRUITINGCincinnati, Ohio, 45219, United States
Contact Email: •••••@•••••
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Other studies related to the condition(s) this trial covers.
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