Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

Starting soon · Not applicable · Has a placebo group

Conditions studied: Solid Tumor, Adult, Cytotoxicity

In brief

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.

Key facts

Study ID: NCT06772090
Run by: Masonic Cancer Center, University of Minnesota
People needed: 40
Starts: 2026-12-25
Expected to finish: 2028-12-31
Last updated by the study team: 2026-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults ≥18 years old
Diagnosis of stage III colon cancer
Undergoing chemotherapeutic treatment within the MHFV or MVAHC medical systems.

You may not qualify if…

Allergy or sensitivity to probiotic supplementation
Diagnosis/history of:
Non-colon GI cancer or chronic GI-related disease or disorders such as gastric ulcer, irritable bowel syndrome, inflammatory bowel disease, or intestinal malabsorption syndrome Cognitive impairment, such as dementia, or developmental disorder that would affect ability to give consent or comply with study procedures
Current treatment of cancer other than non-melanoma skin cancer, including metastases and recurrences
Current participation in another interventional study of medication(s)
Major changes in eating habits within the past 3 months, such as stopping or starting a restricted diet
BMI ≥40 kg/m2 or ≤17 kg/m2
Unexpected change in weight of ˃4.5 kg within the past 6 months

Full record on ClinicalTrials.gov

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