Clinical trial · Interventional
Probiotic Yogurt Supplement in Reducing Diarrhea in Patients With Metastatic Kidney Cancer Being Treated With Vascular Endothelial Growth Factor-Tyrosine Kinase Inhibitor
Assessment of the Role of Bifidobacterium-Containing Food Supplement Activia™ and Bacteriomic Profiling and Other Biomarkers Associated With Vascular Endothelial Growth Factor Tyrosine Kinase Inhibitor (VEGF-TKI)-Induced Diarrhea in Patients With Metastatic Renal Cell Carcinoma (mRCC)
- 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 randomized clinical trial studies how well probiotic yogurt supplement works in reducing diarrhea in patients with kidney cancer that has spread from the primary site to other places in the body (metastatic) and that are being treated with vascular endothelial growth factor-tyrosine kinase inhibitor therapy. Studying samples of blood and stool from patients who eat probiotic yogurt and those who avoid probiotic yogurt may help doctors plan better treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diarrhea | — | UNRESOLVED | — |
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IV Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Micronutrient-Fortified Probiotic Yogurt | Dietary Supplement | — | UNRESOLVED |
| VEGF-TKI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (probiotic yogurt supplement)
- description
- Patients receive probiotic supplement Activia yogurt QD during weeks 2-13 of VEGF-TKI treatment.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Dietary Supplement: Micronutrient-Fortified Probiotic Yogurt
- Drug: VEGF-TKI
- type
- ACTIVE_COMPARATOR
- label
- Arm II (no intervention)
- description
- Patients avoid any intake of yogurt or yogurt-containing foods and refrain from taking/consuming other probiotic supplements for 3 months.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Drug: VEGF-TKI
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC) * Diagnosis of RCC that is defined as metastatic by standard criteria (American Joint Committee on Cancer \[AJCC\] 7th edition, 2010) * Planned treatment with any VEGF-TKI, treatment has not yet begun * Ability to understand and the willingness to sign a written informed consent * Ability to read and write English * Documented consent to participation to include the following study specific procedures: * Be able to provide up to six serial stool collections at home and deliver to FedEx location that day as per standard operating procedure * Have three 10-ml blood samples taken during a routine clinic visit * To not take probiotic supplements except as oriented * If randomized to the probiotic-supplemented group (the yogurt-based supplement Activia), be willing to comply with daily intake and record this intake as a component of a dietary log; the patient will be asked not to take any yogurt or yogurt-containing foods beyond this * If randomized to the probiotic-restricted group, agree not to consume yogurt or yogurt-containing foods * Maintain a dietary log and stool frequency log Exclusion Criteria: * Patients with a known intolerance to lactose or other constituents of Activia * Patients with irritable bowel syndrome, Crohn's disease, or other clinically significant gastrointestinal (GI) related condition that might confound the VEGF-TKI-related-diarrhea endpoint * Patients taking antibiotics or who plan to begin taking antibiotics * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (including compliance issues related to feasibility/logistics)
References
Publications (1)
- DERIVEDDizman N, Hsu J, Bergerot PG, Gillece JD, Folkerts M, Reining L, Trent J, Highlander SK, Pal SK. Randomized trial assessing impact of probiotic supplementation on gut microbiome and clinical outcome from targeted therapy in metastatic renal cell carcinoma. Cancer Med. 2021 Jan;10(1):79-86. doi: 10.1002/cam4.3569. Epub 2020 Nov 1. PMID 33135866