Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

NCT ID: NCT06772090

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-12-25
• Study Completion Date: 2028-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Phase 0: Placebo

The placebo will also be manufactured and provided by the commercial provider.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo capsule manufactured in same facility as experimental capsule.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo capsule manufactured in same facility as experimental capsule.

Phase 1: Treatment

50 billion CFU of a commercially available Lactobacillus and Bifidobacterium oral capsule, to be taken daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Lactobacillus and Bifidobacterium

Intervention Type: 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>).

Interventions

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>).

Intervention Type: BIOLOGICAL

Placebo

Placebo capsule manufactured in same facility as experimental capsule.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ajay Prakash, MD, PhD

Role: CONTACT

praka086@umn.edu

612-624-9452

Other Identifiers

2023LS220

Identifier Type: -

Identifier Source: org_study_id