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Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

NCT06772090 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-25
Primary Completion
2027-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06772090 on ClinicalTrials.gov