Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

NCT06772090 | Not Yet Recruiting DMC

• 1 other identifier: 2023LS220
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants at end of study

  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.

  Week 12

Secondary Outcomes (1)

• Number of Adverse Events related to Cytotoxic Chemotherapy

  Week 12

Study Arms (3)

Phase 0: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Phase 1: Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Phase 1: Treatment

ACTIVE COMPARATOR

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

Biological: Lactobacillus and Bifidobacterium

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\>).

Phase 1: Treatment

Placebo OTHER

Placebo capsule manufactured in same facility as experimental capsule.

Phase 0: Placebo; Phase 1: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

MeSH Terms

Interventions

Lacteol

Central Study Contacts

Ajay Prakash, MD, PhD

CONTACT

612-624-9452; praka086@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 13, 2025
• Study Start (Estimated): December 25, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-02