NCT06772090

Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

A Randomized Placebo-controlled Feasibility Trial of Probiotic Supplementation During Adjuvant or Neoadjuvant Cytotoxic Chemotherapy for Solid Tumor Malignancies

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot single-blind placebo-controlled randomized trial to establish experimental feasibility. We plan on enrolling a pilot cohort of 40 patients, with up to 5 patients in treatment phase 0 and the remaining in treatment phase I. During Phase I, the remaining participants will be assigned to either treatment or control group using dynamic block randomization balancing on sex, age group, and disease histology.

Conditions

• Solid Tumor, Adult
• Cytotoxicity

Interventions

Type	Name	Description
BIOLOGICAL	Lactobacillus and Bifidobacterium	Each lot of Lactobacillus and Bifidobacterium and placebo capsules to be used in this study will undergo bioburden testing (tested as per USP \<61\>) to ensure that each lot has: * Not more than 2000 colony forming unit (CFU) of contaminating (other than the seven strains of bacteria used in the Lactobacillus and Bifidobacterium capsules) aerobic bacteria per gram or dose (whichever is greater); * Not more than 200 CFU of yeasts and molds per gram or dose (whichever is greater); and * No bile-tolerant Gram-negative bacteria, Escherichia coli, Salmonella species (in 10 gm), Pseudomonas aeruginosa, Staphylococcus aureus, and Clostridium species per gram or dose (whichever is greater; tested as per USP\<62\>).
OTHER	Placebo	Placebo capsule manufactured in same facility as experimental capsule.

Timeline

• Start date: 2026-12-25
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-01-13
• Last updated: 2026-02-03