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.

Reference

  1. 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.