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NCT05658263CompletedEarly phase 1

Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet

Source: ClinicalTrials.gov · Last updated 13 May 2025

Brief summary (registry, in English)

The long-term study objective is to develop optimized nutritional therapies for surgery and test them in clinical practice. This pilot study will test a microbiome-optimization diet in colorectal cancer surgery patients. The study hypothesizes that the Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet will provide participants with increased microbiota accessible carbohydrates (MACs) to support the microbiome and improve outcomes.

Status (registry)
Completed
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
14 (actual)
First submitted
11 Oct 2022
Start date
3 Jan 2023
Primary completion date
15 Aug 2024
Lead sponsor
University of Minnesota
NCT number
NCT05658263

What you commit to

  • Study type: Interventional · Early phase 1
  • Participants enrolled: 14
  • From 3 Jan 2023 to the primary completion date, 15 Aug 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous organ transplantation.
  • Depression: A CES-D score more than 16 and a psychologist determining that the patient is not a good fit for surgery.

Other illness

  • If surgery is being performed for any reason other than resection of colon cancer. Neoadjuvant therapy, or if surgery is not the initial approach for the patient's colon cancer treatment
  • History of gastrointestinal surgery including stomach, small bowel or colon resection, pancreatic surgery, bile duct or gallbladder surgery, or splenectomy, or gastric bypass.
  • History of intra-abdominal sepsis.
  • Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
  • History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.
  • Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.
  • Presence of any type of non-MRI compatible implant, including cardiac pacemakers or defibrillators, neurostimulators, cochlear implants, or other metallic hardware
  • Self-reported history of claustrophobia.

Lab values

  • Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy: any personal history of hereditary or acquired bleeding disorder, or thrombocytopenia with platelets under 100,000.
  • Serum creatinine greater than 1.5 mg/dL.
  • Serum total bilirubin greater than the upper limit of normal in the absence of Gilbert's syndrome or alkaline phosphatase or ALT or AST greater than 2.5 times the upper limit of normal. Elevated INR (1.5 or above).

Age

  • Age ≤ 25 years or ≥70 years

Other

  • Alcohol intake more than one drink or greater than 20 grams per day for women or 30 grams per day for men.
  • Currently pregnant or nursing.
  • Body mass index (BMI) \<20 or \> 40 kilograms per meter squared:
    • obesity is known to impact the microbiome and immune system and the occurrence of anastomotic leak, and extreme obesity may confound interpretation of these factors in association to leak. Inferences may be made by matching participants with less severe obesity (BMI \<40).
  • Incarceration
  • Inability to adhere to the study protocol, procedures, and diet
  • Exclusions may also be made at the discretion of the attending physician.

Who the study is looking for

  • Age 25-70 years
  • Primary diagnosis of colon cancer, stages 1-3.
  • Able and willing to provide informed consent.
  • English-speaking.
  • Willingness to return to the study site for specified study visits at D7 and D30.
  • Able to comply with study measures.

Age in the registry: 25 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Minnesota
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.