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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06349590
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High-fiber/low-fat meals — DIETARY_SUPPLEMENT
    Meals with Low fat/High fiber

Study Details

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 High-fiber/low-fat 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.

Key Dates

Start date
Jun 27, 2024
Status verified
Nov 2025
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Dietary Intervention Participants
    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.

Primary Outcome Measure

Change in lab values of the dietary intervention on the collagenolytic potential of the microenvironment. [ Time Frame: At baseline on Day 1 until final values collected on 6 months post-op visit. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637
Benjamin Shogan, MD
[email protected]
773-732-2260
Leila Yazdanbakhsh
[email protected]
773-834-6087
Benjamin Shogan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Chicago· Chicago, IL

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