Phase
Condition
N/ATreatment
Bifidobacterium animalis subsp. lactis Bl-04
Plasebo
Clinical Study ID
Ages 19-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
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) orhave 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
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-supportedyogurt and similar food supplements.
Antibiotic utilization within the past month
Active interstitial lung disease or a history of interstitial lung disease requiringsystemic steroid treatment.
A condition requiring systemic corticosteroids (greater than 10 mg of prednisonedaily or equivalent) or who have received immunosuppressive treatment within 14 daysprior 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 HeartAssociation Functional Classification) or a history of myocarditis.
Uncontrolled cardiac arrhythmia that developed within six months prior to the startof the study.
Study Design
Study Description
Connect with a study center
Necmettin Erbakan University
Konya, 42090
TurkeyActive - Recruiting
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