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High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial) | Clinical Trials | Clareo Health

RECRUITINGNA

High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)

A Randomized High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)

NCT06337552•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods (FF), among locally advanced rectal cancer patients and non-small cell lung cancer (NSCLC) patients, and to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiation and NSCLC patients receiving immunotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 years of age or older
•Diagnosed with locally advanced rectal cancer (Stage II-III)
•Will undergo neoadjuvant chemoradiation at Moffitt Cancer Center
•Able to pick up FFs once/weekly at Moffitt
•Able to speak and read English
•Able to consume foods orally
•Able to provide informed consent
•18 years of age or older
•Diagnosed with stage II-IV non-small cell lung cancer (NSCLC)
•Will undergo Immunotherapy with immune checkpoint inhibitors (+/- chemotherapy or other treatment) at Moffitt Cancer Center
+4 more criteria

Exclusion Criteria

•Antibiotic use within 1 month prior to baseline
•If currently using probiotics, unwillingness to cease probiotic use
•Previous receipt of surgery, immunotherapy, chemotherapy, or radiation for a colon or rectal tumor
•Per clinician's discretion, clinician confirmed inflammatory bowel conditions (e.g., ulcerative colitis, Crohn's disease)
•Infectious disease diagnosed \<1 month prior to baseline
•Already consuming ≥2 servings of fermented foods/day
•Previously diagnosed with a mast cell disorder or histamine allergy

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Key Dates

Start Date

April 4, 2024

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2027

Last Updated

February 9, 2026

Enrollment

ESTIMATED participants

Conditions

Rectal CancerNon-Small Cell Lung Cancer

Interventions

FEED-FF

OTHER

Standard of Care (SUC)

OTHER

Contacts

Stephanie Hogue

CONTACT

813-745-1891 Stephanie.Hogue@moffitt.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)

Inclusion Criteria

Exclusion Criteria

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