Clinical trial NCT05658263: Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet
Official title: Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dysbiosis
Sarcopenia
Colon Cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Age ≤ 25 years or ≥70 years
* 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
* 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).
* Alcohol intake more than one drink or greater than 20 grams per day for women or 30 grams per day for men.
* 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.
* Previous organ transplantation.
* Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
* Currently pregnant or nursing.
* 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.
* Depression: A CES-D score more than 16 and a psychologist determining that the patient is not a good fit for surgery.
* Body mass index (BMI) \&lt;20 or \&gt; 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 \&lt;40).

* 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.
* Incarceration
* Inability to adhere to the study protocol, procedures, and diet
* Exclusions may also be made at the discretion of the attending physician.

Primary outcomes:
measure: Change in muscle mass
timeFrame: baseline and 4 weeks after surgery
measure: Frequency of accidental gas leakage
timeFrame: 4 weeks after surgery
measure: Frequency of accidental mucus leakage
timeFrame: 4 weeks after surgery
measure: Frequency of accidental liquid stool leakage
timeFrame: 4 weeks after surgery
measure: Frequency of bowel movements
timeFrame: 4 weeks after surgery
measure: stool consistency
timeFrame: 4 weeks after surgery
measure: Bowel emptying patterns
timeFrame: 4 weeks after surgery
measure: Laxative/stool softener use
timeFrame: 4 weeks after surgery
measure: Laxative/stool softener use
timeFrame: 4 weeks after surgery
measure: Laxative/stool softener use
timeFrame: 4 weeks after surgery
measure: Laxative/stool softener use
timeFrame: 4 weeks after surgery
measure: Gastrointestinal comfort
timeFrame: 24 hours before surgery
measure: Bowel emptying patterns
timeFrame: 24 hours before surgery
measure: Laxative/stool softener use
timeFrame: 24 hours before surgery
measure: Compliance with the dietary intervention or standard of care- Baseline veggie meter
timeFrame: baseline
measure: Compliance with the dietary intervention or standard of care- Baseline veggie meter
timeFrame: postop day 7
measure: Compliance with the dietary intervention or standard of care- Baseline veggie meter
timeFrame: postop day 30
measure: Compliance with the dietary intervention or standard of care- survey
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in microbiome features- alpha diversity
timeFrame: Baseline, time of surgery, postop day 7 and 30
measure: Change in microbiome features- beta diversity
timeFrame: Baseline, time of surgery, postop day 7 and 30
measure: Fecal metabolites
timeFrame: baseline and 4 weeks after surgery
measure: Fecal inflammatory markers
timeFrame: Baseline and 4 weeks after surgery
measure: Changes in body composition- abdominal muscle
timeFrame: Baseline, time of surgery, postop day 7 and 30
measure: Changes in body composition- psoas muscle
timeFrame: Baseline, time of surgery, postop day 7 and 30
measure: Changes in body composition- volume of fat
timeFrame: Baseline, time of surgery, postop day 7 and 30
measure: Changes in body composition- liver fat
timeFrame: Baseline, time of surgery, postop day 7 and 30
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Cyrus Jahansouz
role: PRINCIPAL_INVESTIGATOR
References: