Clinical trial · Interventional
The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients
The Impact of Bifidobacterium Lactis Supplementation on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients Receiving Immunotherapy (Nivolumab)
NCT06428422CI-TRIAL-00079859recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this study is to evaluate the effect of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on the clinical effectiveness of immunotherapy in patients diagnosed with metastatic non-small cell lung cancer who are receiving immunotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bifidobacterium animalis subsp. lactis Bl-04 | Dietary Supplement | — | UNRESOLVED |
| Plasebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- The intervention group will receive an oral dosage of 4 x 10\^9 cfu/g/day Bifidobacterium animalis subsp. lactis BL-04 strain (Danisco, USA) and 1 gram of maltodextrin (Danisco, USA) in conjunction with the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg/kg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks. A probiotic strain is provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks.
- interventionNames
- Dietary Supplement: Bifidobacterium animalis subsp. lactis Bl-04
- type
- PLACEBO_COMPARATOR
- label
- Plasebo group
- description
- The plasebo group will receive the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg/kg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks. In addition to the traditional treatment (nivolumab), the plasebo group will be given 1 g/day maltodextrin (Danisco, USA) as placebo. Maltodextrin will be provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Volunteering to participate in the study. * Histologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC). * Patients must be in an advanced stage (incurable with surgery or radiotherapy) or have metastatic disease (Stage IV). * Male or female patients aged \>18 years. * Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2. * Laboratory findings must confirm adequate bone marrow function, indicated by: White Blood Cell (WBC) count \> 2,000/mm³, Neutrophil count \> 1,500/mm³,Platelet count \> 100,000/mm³ Exclusion Criteria: * Previously received treatment with any of the following antibody blockers: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4. * Currently taking probiotic supplements or consuming probiotic bacteria-supported yogurt and similar food supplements. * Antibiotic utilization within the past month * Active interstitial lung disease or a history of interstitial lung disease requiring systemic steroid treatment. * A condition requiring systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent) or who have received immunosuppressive treatment within 14 days prior to the first dose of the study. * Presence of uncontrolled adrenal insufficiency. * Pregnancy or breastfeeding. * Severe congestive heart failure (Class III or higher according to the New York Heart Association Functional Classification) or a history of myocarditis. * Uncontrolled cardiac arrhythmia that developed within six months prior to the start of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.