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Dietary Intervention for Colorectal Cancer Recurrence and Metastasis

This study is looking at whether a special diet can help prevent colorectal cancer from coming back or spreading after surgery. If you have colorectal cancer and are scheduled for surgery at the University of Chicago Medicine, you might be able to join. Participants will eat standardized high-fiber/low-fat meals for 21 days before surgery. Researchers will collect blood and stool samples, and tissue from your surgery, to see how the diet affects your body. The main goal is to measure changes in certain lab values related to how the diet impacts the area around the tumor. The study is currently recruiting 80 participants.

Study design
This is a single-arm, prospective study, meaning all 80 participants will receive the same dietary intervention. It is a Phase 1/2 trial conducted at a single center.
What's involved
You would eat standardized high-fiber/low-fat meals for 21 days before surgery and keep a food diary. Blood and stool samples will be collected at various times, including before and after surgery.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 5 years after surgery, or until disease recurrence, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06349590

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

Recruiting
PHASE1Ages 18+InterventionalPrevention
University of Chicago
~80 participants
Updated 2025-11-05 on ClinicalTrials.gov
What's tested:High-fiber/low-fat meals

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in lab values of the dietary intervention on the collagenolytic potential of the microenvironment.
Measured over At baseline on Day 1 until final values collected on 6 months post-op visit.

Conditions

Colorectal Cancer

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Benjamin Shogan · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Benjamin Shogan, MD
[email protected]
773-732-2260
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Must have histologically or cytologically confirmed colorectal adenocarcinoma.
Planned for primary tumor resection at the University of Chicago Medicine ≥21 from date of obtained informed consent. Patients with metastatic disease but undergoing primary site resection are eligible for the study.
Age ≥18 years.
Patients \<18 years of age, children are excluded from this study, because they have unique nutritional requirements that might not be met by with the standardized diet. The food in the diet is designed for adults and would not be feasible for children, especially those attending school. In addition, colon cancer is extremely rare in children.
May have received neoadjuvant therapy (chemotherapy, radiation).
Patients with Hepatic arterial infusion (HAI) pumps are considered eligible.
Ability to understand and willing to sign an informed consent, participate in the dietary intervention, collect stools, donate blood, and complete a pre-nutritional evaluation and compliance/patient satisfaction survey.

Exclusion

Previous ostomy (ileostomy or colostomy) or definitive plan for an ostomy (ileostomy or colostomy) during the procedure.
Antibiotic exposure within 60 days before diet initiation. Antibiotic exposure is defined as a 'course of treatment to treat an infection'. Prophylactic antibiotics prior to a procedure is okay.
Prebiotic/Probiotic exposure within 60 days before diet initiation.
Concomitant separate malignancy.
Allergy to perioperative medications (oral neomycin/metronidazole for bowel preparation, intraoperative prophylactic intravenous cefazolin and metronidazole).
Patients who are pregnant are not eligible for the study. Pregnant women are excluded from this study because the preoperative diet is not specifically formulated to meet the specific nutritional requirements during the prenatal period.
History of inflammatory bowel disease
Severe food allergies precluding the ability to tolerate the standardized dietary intervention.
Patients with uncontrolled intercurrent illness

What this trial measures

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

    To assess whether the dietary intervention significantly changed the collagenase activity, the site will compare each subject's baseline and final values.