Clinical trial · Interventional
Engineering Gut Microbiome to Target Breast Cancer
NCT03358511CI-TRIAL-00045203completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to find out if using probiotics will help the body's immune system react to breast cancer. New studies showed that diverse species of bacteria inside the bowel might help improve immune system, particularly the ability of immune system to recognize cancer. This study will investigate how probiotics will affect the subjects' immune system on breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Probiotic | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast Cancer Patients
- description
- All subjects will be given 2-4 weeks of probiotics prior to surgery in operable stage I-III breast adenocarcinoma tumors ≥1.0 cm. Subjects will take the probiotic three times a day.
- interventionNames
- Dietary Supplement: Probiotic
Primary outcomes (1)
- measure
- Mean number of cytotoxic T lymphocytes (CD8+ cells)
- timeFrame
- Approximately 4 weeks after baseline
- description
- CD8+ T cells (often called cytotoxic T lymphocytes) are very important for immune defence against intracellular pathogens, including viruses and bacteria, and for tumor surveillance.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Post-menopausal females ≥ 18 years of age * Histologically confirmed adenocarcinoma of the breast ≥1.0 cm operable stage I-III * Must have adequate organ function, * Not receive systemic neoadjuvant therapy * Be willing to provide tissue, blood, and stool samples for research study. * Must not have taken any probiotics in the past 60 days prior to enrollment. Exclusion Criteria: * Patients with autoimmune disease, immune deficiency such as HIV, irritable bowel, known diverticulosis, and other serious GI conditions at treating physician's discretion will be excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.