The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-90
SponsorNecmettin Erbakan University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Bifidobacterium animalis subsp. lactis Bl-04
- Plasebo
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Necmettin Erbakan University
Lead sponsor
Health Institutes of Turkey
Collaborator
Source ClinicalTrials.gov