Clinical trial · Interventional
Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies
A Randomized Placebo-controlled Feasibility Trial of Probiotic Supplementation During Adjuvant or Neoadjuvant Cytotoxic Chemotherapy for Solid Tumor Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cytotoxicity | — | UNRESOLVED | — |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lactobacillus and Bifidobacterium | Biological | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Phase 0: Placebo
- description
- The placebo will also be manufactured and provided by the commercial provider.
- interventionNames
- Other: Placebo
- type
- PLACEBO_COMPARATOR
- label
- Phase 1: Placebo
- description
- 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.
- interventionNames
- Other: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Phase 1: Treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available