RecruitingNot ApplicableNCT06428422
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)
Sponsor
Necmettin Erbakan University
Enrollment
100 participants
Start Date
Aug 12, 2024
Study Type
INTERVENTIONAL
Summary
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.
Eligibility
Min Age: 19 YearsMax Age: 90 Years
Inclusion Criteria7
- 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 Criteria9
- 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.
Interventions
DIETARY_SUPPLEMENTBifidobacterium animalis subsp. lactis Bl-04
4 x 10\^9 cfu/g/day Bifidobacterium animalis subsp. lactis Bl-04 for 12 weeks
OTHERPlasebo
1 g/day maltodextrin for 12 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06428422