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The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients

ConditionMetastatic Non-small Cell Lung Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Bifidobacterium animalis subsp. lactis Bl-04

    Dietary supplement

    4 x 10\^9 cfu/g/day Bifidobacterium animalis subsp. lactis Bl-04 for 12 weeks

  • Plasebo

    Other intervention

    1 g/day maltodextrin for 12 weeks

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Plasebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of Clinical Response

The clinical impact of the immunotherapy will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1 criteria based on radiological analysis.

Time frame
Week 12
2

Progression-free survival

The progression-free survival (PFS) period will be defined as the interval between the initiation of treatment and the date of radiological progression.

Time frame
Basaline and the date of radiological progression
3

Overall survival

The overall survival (OS) period will be defined as the interval between the date of disease diagnosis and death from any cause.

Time frame
Basaline and the date of death from any case

Secondary outcomes

1

Intestinal microbiota modulation

Microbiota and fatty acid analyses, including acetic acid, propionic acid, and butyric acid, will be conducted on fecal samples."

Time frame
Basaline and Week 12
2

Immunological findings

The concentrations of CD4+ T cell subgroups (Th1, Th2, Th9, Th17, Th1Th17, and Treg) and sitokins (IL-1β, IL-4, IL-10, IL-17, TNF-α, TGF-beta, IFN-gamma, IL-36 and trimethylamine N-oxide) will be quantified in the serum samples of the patients.

Time frame
Basaline and Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Necmettin Erbakan University

Lead sponsor

Health Institutes of Turkey

Collaborator

Source ClinicalTrials.gov
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