Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428422
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-20
Brief Title:
The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients
Sponsor:
Necmettin Erbakan University
Organization:
Necmettin Erbakan University
Study Overview
Official Title:
The Impact of Bifidobacterium Lactis Supplementation on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients Receiving Immunotherapy Nivolumab
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Despite modern treatments lung cancer remains a leading cause of high mortality worldwide Over the past decade significant improvements in patient survival have been achieved with immune checkpoint inhibitors which enhance the T cell-mediated immune response to eradicate cancer cells However therapeutic resistance drug side effects and heterogeneous treatment responses limit their effectiveness Recent studies have established a clear relationship between gut microbiota and cancer immunotherapy The intestinal microbiota has been shown to stimulate the anti-tumor immune response by modulating immune system cells Evidence from preclinical and clinical studies indicates that gut microbiota plays a crucial role in the efficacy of immunotherapy and the modulation of drug toxicity Identifying the microbiota as a potential biomarker could facilitate personalized treatment protocols Genetic epigenetic and microbiota modulation factors are essential for optimizing cancer immunotherapy outcomes Consequently research is increasingly focusing on personalized treatment protocols for microbiota modulation including diet regulation fecal microbiota transfer prebiotics and probiotics There has been a significant rise in studies demonstrating the clinical benefits of microbial therapy products as complementary treatments
The functional role of microbiota in modulating the systemic immune response has prompted investigations into its impact on cancer immunotherapy particularly with agents targeting immunological checkpoints like PD-1 Recent studies have identified both positive and negative regulatory bacteria that influence immunotherapy effectiveness However sociocultural and dietary lifestyle differences affect gut microbiota composition leading to variations between populations Therefore studies are needed to identify the unique microbiome composition of each population to develop microbiota biological indicators for cancer immunotherapy No research has been conducted in this area in Türkiye This study aims to identify bacterial species that may serve as biomarkers for the microbiota specific to Turkish cancer patients receiving immunotherapy and use them for prognostic purposes
Understanding the significant role of probiotics in modulating intestinal microbiota has increased the demand for these food supplements Studies show that anti-tumor efficacy is specific to the bacterial strain For instance Bifidobacteriums have been reported to enhance the effectiveness of PD-1 blockers in experimental rat models In another study B lactis BL-04 reduced immunotherapy-induced colitis in animals
This study will investigate the effect of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on clinical objective response clinical benefit rates and intestinal microbiota in patients with metastatic non-small cell lung cancer mNSCLC receiving nivolumab The results may facilitate the development of specific probiotic supplements as a complementary therapy for mNSCLC treatment
The functional role of microbiota in modulating the systemic immune response has prompted investigations into its impact on cancer immunotherapy particularly with agents targeting immunological checkpoints like PD-1 Recent studies have identified both positive and negative regulatory bacteria that influence immunotherapy effectiveness However sociocultural and dietary lifestyle differences affect gut microbiota composition leading to variations between populations Therefore studies are needed to identify the unique microbiome composition of each population to develop microbiota biological indicators for cancer immunotherapy No research has been conducted in this area in Türkiye This study aims to identify bacterial species that may serve as biomarkers for the microbiota specific to Turkish cancer patients receiving immunotherapy and use them for prognostic purposes
Understanding the significant role of probiotics in modulating intestinal microbiota has increased the demand for these food supplements Studies show that anti-tumor efficacy is specific to the bacterial strain For instance Bifidobacteriums have been reported to enhance the effectiveness of PD-1 blockers in experimental rat models In another study B lactis BL-04 reduced immunotherapy-induced colitis in animals
This study will investigate the effect of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on clinical objective response clinical benefit rates and intestinal microbiota in patients with metastatic non-small cell lung cancer mNSCLC receiving nivolumab The results may facilitate the development of specific probiotic supplements as a complementary therapy for mNSCLC treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None