Actively Recruiting
Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery
Led by University of Chicago · Updated on 2025-11-05
80
Participants Needed
1
Research Sites
274 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed colorectal adenocarcinoma by tissue analysis.
- Planned for primary tumor resection at University of Chicago Medicine at least 21 days after informed consent.
- Age 18 years or older.
- May have received chemotherapy or radiation before surgery.
- Patients with hepatic arterial infusion pumps are eligible.
- Able to understand and willing to sign informed consent.
- Willing to participate in the dietary intervention, collect stool samples, donate blood, and complete evaluations and surveys.
You will not qualify if you...
- Previous ostomy or planned ostomy during surgery.
- Antibiotic treatment within 60 days before starting the diet (except prophylactic use).
- Use of prebiotic or probiotic supplements within 60 days before diet start.
- Having another separate cancer.
- Allergy to specific perioperative medications.
- Pregnant women.
- History of inflammatory bowel disease.
- Severe food allergies preventing participation in the diet.
- Uncontrolled other illnesses.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
B
Benjamin Shogan, MD
CONTACT
T
Teresa Barry
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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