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NCT06349590Not yet recruiting

Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery

A Phase 1/2 Study of Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery (The DIET Trial)
University of ChicagoPhase 1/2ClinicalTrials.govdietary supplement
Study focus
Disease/Condition
Colorectal Cancer
Drug/Device/Intervention
Plant-Based Meals
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
University of Chicago
Location
Chicago, United States of America
Timeline & enrollment
Phase
Phase 1/2
Start date
Apr 01, 2024
End date
Apr 01, 2029
Enrollment
20 participants
Primary outcome

Change of the presence of active-urokinase-type plasminogen activation (uPA) stool samples before and after diet intervention using western blot and zymography.

Summary

A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects
 diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from
 informed consent. Subjects will be provided 21 days of standardized plant-based low fat/
 high-fiber meals and complete a food diary up until lunch on the day prior to surgery. Blood
 samples will be collected at baseline and on the day of surgery. Stool samples will be
 collected throughout the dietary intervention period at specific timepoints, on the day of
 surgery, and 30 days post-surgery. Tissue from the tumor resection will be isolated for
 organoid cultures. Subjects will be followed per standard of care for up to 5 years or
 disease recurrence, whichever comes first. Subject may be treated for their cancer prior to
 surgery and/or during the follow-up period.

ICD-10 classifications
Malignant neoplasm of colonMalignant neoplasm: Descending colonMalignant neoplasm: Colon, unspecifiedMalignant neoplasm: Ascending colonMalignant neoplasm: Overlapping lesion of colon
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06349590
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06349590 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by University of Chicago and is currently Not yet recruiting. The study focuses on Colorectal Cancer. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.