Clinical trial · Interventional
Effects of Probiotics on the Gut Microbiome and Immune System in Operable Stage I-III Breast or Lung Cancer
Engineering Gut Microbiome to Target Cancer-Immune Microenvironment in Breast and Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial evaluates whether engineering gut microbiome using probiotics will alter the body's immune system to react to stage I-III breast or lung cancers that can be removed by surgery (operable). Having diverse species of bacteria inside the bowel may help improve the immune system, particularly the ability of the immune system to recognize cancer. Taking probiotics may change the diversity and make up of the bacteria in the bowels, and change how the immune system reacts to breast or lung cancer.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Breast Adenocarcinoma | Breast Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage III Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Probiotic | Drug | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (biospecimen collection, probiotic)
- description
- Patients undergo collection of blood samples at baseline and time of surgery, and collection of stool samples at baseline and after completion of probiotic regimen. Patients receive probiotics PO once on day 1, and then BID or TID for 2-4 weeks before standard of care surgery. Patients also undergo collection of tissue samples during standard of care surgery.
- interventionNames
- Procedure: Biopsy
- Procedure: Biospecimen Collection
- Drug: Probiotic
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (3)
- measure
- Length and adherence of probiotics
- timeFrame
- Up to 4 weeks
- description
- Will be collected via study diaries.
- measure
- Percentage of CD8+, CD4+, and T-reg cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \>= 18 years of age * Histologically confirmed adenocarcinoma of the breast operable stage I-III or histologically confirmed carcinoma of the lung operable stage I-III will be enrolled prior to their definitive surgery * Patients must have adequate organ function * Patients must be willing to provide tissue, blood and stool samples for the research study Exclusion Criteria: * Patients must not receive systemic neoadjuvant therapy * Patients must not have taken any probiotics in the past 30 days prior to the enrollment * Patients with autoimmune disease, immune deficiency such as human immunodeficiency virus (HIV), irritable bowel, known diverticulosis, and other serious gastrointestinal (GI) conditions at treating physician's discretion will be excluded
References
Publications (0)
Data not yet available