Title: A Phase I and Randomized Controlled Phase II Trial of the Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer1
Principal Investigator: Mathew Ciorba, MD, Washington University School of Medicine
Description: For this randomized phase 1/2 study (ClinicalTrials.gov Identifier: NCT01790035), researchers are investigating the effectiveness of probiotic Lactobacillus rhamnosus GG (LGG) in reducing the incidence of acute toxicity among patients with gastrointestinal cancers receiving chemoradiation.
One-hundred and twenty patients will be randomly assigned to receive oral LGG (1010 viable bacteria) twice daily or placebo at baseline at least 3 days before initiation until 2 weeks following radiotherapy. Patients who opt not to receive LGG will not undergo randomization and will receive standard of care radiotherapy; the first 20 patients will serve as a non-intervention comparator cohort.
The primary outcome of the study is to assess the safety, tolerability, and efficacy of LGG among patients receiving abdominal or pelvic chemoradiation with a fluoropyrimidine-based regimen.
Estimated study enrollment is 120 patients.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT01790035.
Status: Open and recruiting patients as of January 16, 2018.
This study is sponsored by the Washington University School of Medicine.
- ClinicalTrials.gov. Probiotic LGG for prevention of side effects in patients undergoing chemoradiation for gastrointestinal cancer (LGG). NCT01790035. https://clinicaltrials.gov/ct2/show/NCT01790035. Accessed January 16, 2017.