drugset / Trial / NCT06772090
Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies
RandomizedParallel-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2026-12-25
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lactobacillus and Bifidobacterium | Unknown | 5e+10 unknown | Oral |