Gut bacteria boost? new trial tests probiotic alongside cancer drugs
NCT ID NCT07191405
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether adding a probiotic called Lactobacillus johnsonii to standard chemotherapy and immunotherapy can help control advanced lung, breast, or stomach cancers. About 156 adults aged 18-75 will be randomly assigned to receive either the probiotic or a placebo alongside their regular treatment. The main goal is to see if the probiotic extends the time before the cancer worsens.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lactobacillus johnsonii (a probiotic bacteria)
- What this could lead to
- If it works, this could show that adding a specific probiotic to standard cancer treatment helps control tumor growth and improves how well the immune therapy works.
- What could go wrong
- This is an early-stage trial with only 156 participants, so results may not apply to everyone. The probiotic might not provide any additional benefit over standard treatment, and there is a risk of side effects from the combination therapy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 156 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed informed consent. 2. Age 18-75 years. 3. Histologically confirmed unresectable/metastatic tumors: EGFR/ALK wild-type adenocarcinoma non-small cell lung cancer (NSCLC) PD-L1+ (CPS≥1) triple-negative breast cancer (TNBC) HER2- gastric/gastroesophageal adenocarcinoma 4. ≥1 measurable lesion (RECIST v1.1). 5. Progression after PD-1/PD-L1 inhibitor therapy (defined as: * ≥2 doses administred. * Radiographic progression per RECIST/iRECIST/irRECIST, confirmed ≥4 weeks later. * Progression within 12 weeks of last PD-1/PD-L1 dose. 6. Adequate organ function. 7. ECOG performance status 0-1. 8. Negative pregnancy test (urine/serum β-HCG) for women of childbearing potential. Exclusion Criteria: * 1\. Prior allogeneic transplantation (cells, tissues, or solid organs). 2. History of immune-related adverse events (irAEs) from immunomodulators (e.g., PD-1/PD-L1 or CTLA-4 inhibitors) leading to permanent discontinuation or Grade 3/4 severity. 3\. Recent anticancer therapy (chemotherapy/immunotherapy/biologics/experimental drugs) within: \<5 half-lives of the drug or \<21 days before starting study treatment (whichever is shorter). Exceptions: Stable hormone therapy (e.g., for prostate/breast/ovarian cancer). 4\. Concomitant corticosteroid use (\>10 mg prednisone/day or equivalent) within 7 days prior to treatment, unless for physiological replacement (≤10 mg/day) or non-immunosuppressive purposes (e.g., inhaled/topical steroids). 5\. Severe cardiac dysfunction, including: NYHA Class III-IV heart failure, symptomatic coronary artery disease, severe ventricular arrhythmias, myocardial infarction/unstable angina within 6 months. 6\. Active autoimmune disease requiring systemic treatment (immunosuppressants/corticosteroids) in the past 2 years, except: Hormone replacement (thyroxine, insulin, physiologic corticosteroids). 7\. Active severe infection requiring systemic therapy. 8. Antibiotic use completed within 2 weeks before the first dose. 9. Psychiatric or substance abuse disorders compromising protocol compliance. 10. Live vaccines administered within 28 days before treatment. 11. Active HIV or hepatitis (A/B/C) infection. 12. History of steroid-requiring (non-infectious) pneumonitis or current active pneumonitis. 13\. Other malignancies requiring active treatment or progressing within 2 years (exceptions: Non-melanoma skin cancer, cervical/prostate carcinoma in situ). 14\. Pregnancy or lactation. 15. Known intolerance/allergy to study drugs. 16. Other conditions deemed unsuitable by investigators.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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