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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 0: Placebo | Placebo Comparator | The placebo will also be manufactured and provided by the commercial provider. |
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| 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. |
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| Phase 1: Treatment | Active Comparator | 50 billion CFU of a commercially available Lactobacillus and Bifidobacterium oral capsule, to be taken daily for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events related to Cytotoxic Chemotherapy | 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. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ajay Prakash, MD, PhD | Contact | 612-624-9452 | praka086@umn.edu |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
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| Placebo | Other | Placebo capsule manufactured in same facility as experimental capsule. |
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