Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

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.

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Key information

Conditions

Solid Tumor, Adult Cytotoxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Number of Participants at end of study

Time frame: Week 12

Determine the feasibility of conducting a randomized, placebo controlled clinical trial of probiotic supplementation in patients with solid tumor malignancies undergoing cytotoxic chemotherapeutic treatment. Number of participants that completed the study.

Secondary outcomes

Number of Adverse Events related to Cytotoxic Chemotherapy

Time frame: Week 12

To evaluate how probiotic supplementation impacts cytotoxic chemotherapy-associated GI toxicities, including nausea, anorexia, and diarrhea. Number of adverse events correlated to nausea, anorexia or diarrhea.

Study contacts

Contact information is provided by the study sponsor or research team.

Ajay Prakash, MD, PhD

CONTACT

[email protected]

612-624-9452

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Jan 13, 2025
Registry last updated: Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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