Probiotic for GI Issues During Pelvic Radiation
This study is looking at whether an oral probiotic called Pendulum Glucose Control (PGC) can be safely given to people receiving radiation therapy to the pelvis. The goal is to see if this probiotic can help reduce stomach and bowel side effects (gastrointestinal toxicity) that often happen during pelvic radiation. You might be able to join if you are at least 18 years old and are receiving at least 30 Gy of pelvic radiation for certain cancers, including lower GI cancers (like anal or rectal), gynecologic cancers (like cervical or prostate cancer with lymph node involvement). Researchers will measure how well participants stick to taking the probiotic to determine if this approach is practical for future studies.
- Study design
- This is an interventional study with a planned enrollment of 20 participants. It is a pilot feasibility trial, meaning it's an early study to see if the treatment is practical.
- What's involved
- You would take 2 capsules of Pendulum Glucose Control (PGC) orally with food once daily for 10 weeks. Your adherence to taking the probiotic will be measured by pill counts at Week 6 and Week 10.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at Week 6 and Week 10, indicating the duration of the intervention and observation period.
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Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Pendulum Glucose Control (PGC) Probiotic Adherence Rate (PAR)- measured by pill countsWeek 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.