NCT06428422Recruiting
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)
Source: ClinicalTrials.gov · Last updated 16 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 20 May 2024
- Start date
- 12 Aug 2024
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Necmettin Erbakan University
- Diseases
- Lung cancer
- NCT number
- NCT06428422
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 12 Aug 2024 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- A condition requiring systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent) or who have received immunosuppressive treatment within 14 days prior to the first dose of the study.
- Uncontrolled cardiac arrhythmia that developed within six months prior to the start of the study.
Other illness
- Active interstitial lung disease or a history of interstitial lung disease requiring systemic steroid treatment.
- Presence of uncontrolled adrenal insufficiency.
- Severe congestive heart failure (Class III or higher according to the New York Heart Association Functional Classification) or a history of myocarditis.
Other
- Antibiotic utilization within the past month
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
- 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
Age in the registry: 19 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Necmettin Erbakan University Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.