Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in muscle mass
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25-70 years
- •Primary diagnosis of colon cancer, stages 1-
- •Able and willing to provide informed consent.
- •English-speaking.
- •Willingness to return to the study site for specified study visits at D7 and D
- •Able to comply with study measures.
排除标准
- •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,
- •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) <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).
- •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.
结局指标
主要结局
Change in muscle mass
时间窗: baseline and 4 weeks after surgery
The change in muscle mass assessed by MRI-measured area and density of the psoas muscle at the level of the L3 vertebra with adjunct grip strength measurement.
Frequency of accidental mucus leakage
时间窗: 4 weeks after surgery
this will be assessed in times per day or times per month
stool consistency
时间窗: 4 weeks after surgery
Bristol Stool Chart: Type 1 (hard lumps) through Type 7 (watery, no solid pieces, entirely liquid
Laxative/stool softener use
时间窗: 24 hours before surgery
range; 0-4+ doses
Bowel emptying patterns
时间窗: 24 hours before surgery
includes constipation, diarrhea, urgency; range: 0 (never) --\> 4 (always)
Frequency of accidental gas leakage
时间窗: 4 weeks after surgery
this will be assessed in times per day or times per month
Gastrointestinal comfort
时间窗: 24 hours before surgery
range: 0 (no problem) --\> 4 (very strong discomfort)
Compliance with the dietary intervention or standard of care- Baseline veggie meter
时间窗: postop day 30
carotenoid score, triplicate measurement; range: 0 (lower estimated value)-800 (arbitrary units; higher estimated value correlates with greater carotenoid concentrations
Frequency of accidental liquid stool leakage
时间窗: 4 weeks after surgery
this will be assessed in times per day or times per month
Frequency of bowel movements
时间窗: 4 weeks after surgery
this will be assessed in numbers per day or numbers per week
Compliance with the dietary intervention or standard of care- survey
时间窗: 4 weeks
24-hour diet recall surveys conducted by Nutrition Coordinating Center at University of Minnesota
次要结局
- Change in microbiome features- beta diversity(Baseline, time of surgery, postop day 7 and 30)
- Change in microbiome features- alpha diversity(Baseline, time of surgery, postop day 7 and 30)
- Fecal inflammatory markers(Baseline and 4 weeks after surgery)
- Changes in body composition- liver fat(Baseline, time of surgery, postop day 7 and 30)
- Fecal metabolites(baseline and 4 weeks after surgery)
- Changes in body composition- abdominal muscle(Baseline, time of surgery, postop day 7 and 30)
- Changes in body composition- psoas muscle(Baseline, time of surgery, postop day 7 and 30)
- Changes in body composition- volume of fat(Baseline, time of surgery, postop day 7 and 30)