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

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study is looking at whether taking a daily probiotic supplement can help improve survival and treatment outcomes in people with stage IV (metastatic) non-small cell lung cancer. The gut microbiome may influence how the immune system responds to cancer treatments, and this trial aims to explore that connection. **You may be eligible if...** - You are over 18 years old - You have been confirmed to have non-small cell lung cancer (NSCLC) - Your cancer is in an advanced or metastatic stage (Stage IV) - You are healthy enough to be up and about for most of the day (ECOG less than 2) - Your blood counts (white cells, neutrophils, and platelets) are at acceptable levels **You may NOT be eligible if...** - You have previously been treated with certain immunotherapy drugs (anti-PD-1, anti-PD-L1, anti-CTLA-4 or related agents) - You are currently taking probiotic supplements or consuming probiotic yogurt - You have taken antibiotics in the past month - You have active interstitial lung disease or a history of it requiring steroids - You need regular high-dose steroids or immunosuppressants - You have severe heart failure or a history of myocarditis (heart inflammation) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Necmettin Erbakan University

Konya, Turkey (Türkiye)

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NCT06428422


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