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Search / Trial NCT06610097

TNBC Gut Microbiota During Neoadjuvant Treatment

Launched by SCRIPPS HEALTH · Sep 19, 2024

Trial Information

Current as of August 29, 2025

Recruiting

Keywords

Gut Microbiome Triple Negative Breast Cancer High Fiber Diet Immunotherapy

ClinConnect Summary

This clinical trial is studying how a high-fiber diet may affect the gut microbiome in patients with early-stage triple-negative breast cancer (TNBC) who are receiving treatment before surgery. The gut microbiome is the community of tiny organisms living in our digestive system, and it can influence our overall health. Researchers want to find out if improving the gut microbiome through dietary changes, specifically by increasing fiber intake, can lead to better health outcomes for these patients. Up to 30 participants will be recruited to either follow a personalized high-fiber diet with guidance from a dietitian or receive educational handouts about nutrition during their treatment.

To be eligible for this study, participants must be at least 18 years old, diagnosed with early-stage TNBC, and not currently undergoing certain therapies. They should also be able to communicate in English at an 8th-grade level or higher. Throughout the trial, participants can expect nutritional counseling and support, along with tracking their physical activity and mood. After completing the study, participants will have one-on-one interviews to share their experiences and satisfaction with the supportive care they received. This trial aims to explore the connection between diet and gut health during cancer treatment, potentially offering new insights into how nutrition can support patients fighting breast cancer.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • Prebiotic and/or probiotic use prior to and during the study

About Scripps Health

Scripps Health is a leading nonprofit healthcare organization based in San Diego, California, dedicated to advancing medical research and improving patient care through innovative clinical trials. With a commitment to excellence, Scripps Health integrates cutting-edge technology and evidence-based practices to explore new treatments and therapies across various medical disciplines. Their robust network of healthcare professionals and research specialists fosters a collaborative environment, enabling the development of groundbreaking solutions that enhance health outcomes for diverse patient populations. Through rigorous scientific inquiry and a patient-centered approach, Scripps Health continues to contribute significantly to the advancement of medical knowledge and the improvement of community health.

Locations

La Jolla, California, United States

Patients applied

0 patients applied

Trial Officials

Lee Hong, MD, PhD

Principal Investigator

Scripps Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported