Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT06772090
Status
Not Yet Recruiting

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Conditions

  • Cytotoxicity
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lactobacillus and Bifidobacterium — BIOLOGICAL
    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\>).
  • Placebo — OTHER
    Placebo capsule manufactured in same facility as experimental capsule.

Study Details

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 Dates

First listed
Jan 13, 2025
Start date
Dec 25, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Placebo Comparator: Phase 0: Placebo
    The placebo will also be manufactured and provided by the commercial provider.
  • Placebo Comparator: Phase 1: Placebo
    Placebo capsules of the same size and shape to be taken daily for 12 weeks. The placebo will also be manufactured and provided by the commercial provider.
  • Active Comparator: Phase 1: Treatment
    50 billion CFU of a commercially available Lactobacillus and Bifidobacterium oral capsule, to be taken daily for 12 weeks

Primary Outcome Measure

Number of Participants at end of study [ Time Frame: Week 12 ]

Central Contacts

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