Status:
RECRUITING
TNBC Gut Microbiota During Neoadjuvant Treatment
Lead Sponsor:
Scripps Health
Collaborating Sponsors:
San Diego State University
The Scripps Research Institute
Conditions:
Breast Cancer
Triple Negative Breast Cancer
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The gut microbiome is made up of the microbes (such as bacteria, viruses, and other organisms too small to see with the naked eye) that live in the digestive tract and has been shown to be important i...
Detailed Description
This is a randomized, prospective study with a small group of 30 patients (pilot study). Once participants are enrolled, they will be randomized in a 2:1 ratio of either the nutritional intervention (...
Eligibility Criteria
Inclusion
- Diagnosis of early-stage triple-negative breast cancer, not on neoadjuvant systemic therapy at the time of enrollment.
- Age greater than or equal to 18 years and less than 100 years
- English proficiency at or above 8th grade level
- Expected survival greater than or equal to 12 months
Exclusion
- Prebiotic and/or probiotic use prior to and during the study
Key Trial Info
Start Date :
March 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06610097
Start Date
March 7 2025
End Date
June 30 2026
Last Update
April 23 2025
Active Locations (1)
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1
Scripps Clinic
La Jolla, California, United States, 92037