Actively Recruiting
The Impact of Bifidobacterium Lactis Supplementation on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients Receiving Immunotherapy (Nivolumab)
Led by Necmettin Erbakan University · Updated on 2024-08-16
100
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
Sponsors
N
Necmettin Erbakan University
Lead Sponsor
H
Health Institutes of Turkey
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on the effectiveness of immunotherapy in patients diagnosed with metastatic non-small cell lung cancer (mNSCLC). This study focuses on patients receiving immunotherapy with nivolumab and aims to explore how gut microbiota influences treatment response, survival, and side effects. The study is particularly interested in identifying microbiota biomarkers specific to Turkish cancer patients to support personalized treatment approaches. Participants are randomly assigned to one of two groups. The intervention group receives an oral dose of 4 x 10^9 cfu/g/day of Bifidobacterium animalis subsp. lactis BL-04 alongside standard immunotherapy with nivolumab administered intravenously every two weeks for twelve weeks. The placebo group receives nivolumab with a daily maltodextrin sachet instead of the probiotic. Both groups follow this 12-week immunotherapy and supplementation schedule. During the study, participants undergo evaluations of clinical response, progression-free survival, and overall survival, with measurements taken at baseline and after 12 weeks. Researchers also assess changes in intestinal microbiota and immune system markers. Safety is monitored throughout the treatment period. The total participation duration spans the treatment period with follow-up on clinical outcomes. This information may help develop probiotic supplements as complementary therapies for mNSCLC treatment.
CONDITIONS
Brief Title
The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Adequate bone marrow function with white blood cell count > 2,000/mm³, neutrophil count > 1,500/mm³, and platelet count > 100,000/mm³.
You will not qualify if you...
- Previously received treatment with any 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.
- Antibiotic use within the past month.
- Active interstitial lung disease or history requiring systemic steroid treatment.
- Need for systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive treatment within 14 days before first dose.
- Uncontrolled adrenal insufficiency.
- Pregnancy or breastfeeding.
- Severe congestive heart failure (Class III or higher) or history of myocarditis.
- Uncontrolled cardiac arrhythmia developed within six months before study start.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive oral probiotic or placebo daily and immunotherapy with nivolumab intravenously every two weeks for 12 weeks.
Weekly visits for 12 weeks with nivolumab infusions every two weeks
Trial Site Locations
Total: 1 location
1
Necmettin Erbakan University
Konya, Turkey (Türkiye), 42090
Actively Recruiting
Research Team
M
Mehmet Artaç, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here