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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 years
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Blood samples will be collected at baseline and on the day of surgery."
- "Subjects will be followed per standard of care for up to 5 years or disease recurrence, whichever comes first."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a high-fiber, low-fat diet before surgery can change gut bacteria and help keep colorectal cancer from coming back or spreading. It is for adults with colon or rectal cancer who are scheduled for surgery at least 21 days after agreeing to join. Participants get 21 days of meals and keep a food diary.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older.
- Tests on tissue or cells show colorectal adenocarcinoma, a type of colon or rectal cancer.
- You plan to have the main tumor removed at University of Chicago Medicine at least 21 days after agreeing to join.
- You may join even if the cancer has spread, as long as the main tumor will be removed.
- You may have had chemotherapy or radiation before surgery.
- You may have a hepatic arterial infusion (HAI) pump, which delivers medicine to the liver.
- You can understand and sign the consent form and agree to follow the diet, collect stool samples, give blood, complete a nutrition check, and answer a survey.
Who can't join
- You already have, or plan to have, an ostomy—an opening in the belly that lets stool leave the body.
- You took antibiotics to treat an infection within 60 days before starting the diet. Antibiotics to prevent infection before a procedure are allowed.
- You used prebiotics or probiotics—products that feed or add helpful gut bacteria—within 60 days before starting the diet.
- You have another separate cancer at the same time.
- You are allergic to the surgery-related antibiotics neomycin, metronidazole, or cefazolin, or have severe food allergies that keep you from following the diet.
- You are pregnant.
- You have a history of inflammatory bowel disease, which causes swelling in the digestive tract.
- You have another illness that is not under control.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
Study sites (1)
IL
- University of Chicago · Chicago, IL 60637Benjamin Shogan, MD · Study contact · 773-732-2260 · bshogan@bsd.uchicago.eduLeila Yazdanbakhsh · Study contact · 773-834-6087 · leila.yazdanbakhsh@bsd.uchicago.eduBenjamin Shogan, MD · Principal investigatorMore trials in Chicago