Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies (NCT06772090) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies
40 participantsStarted 2026-12-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants at end of study
Timeframe: Week 12
Trial details
NCT IDNCT06772090
SponsorMasonic Cancer Center, University of Minnesota