Clinical trial NCT04869956: Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery
Official title: Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Microbiome
Surgery
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open, controlled, randomized clinical trial
Primary purpose: TREATMENT

Brief summary: The investigators will conduct an open, controlled, randomized clinical trial, in patients with scheduled surgical intervention for CRC in the General Surgery and Digestive System Unit of the Virgen de la Arrixaca University Hospital (Murcia, Spain). All the included individuals must have passed the protocol of the Virgen de la Arrixaca University Hospital to be candidates for elective major surgery for CRC and must sign the informed consent after being informed of the objectives and the methodology of the study. The Helsinki Declaration will be followed during the duration of the project.

Patients will be randomized in a 1:1 ratio after receiving a diagnosis of CRC in the endoscopic evaluation; in the control arm, patients will receive standard nutritional recommendations, while patients in the intervention arm will be advised to follow a high-fiber diet rich in PUFAs (total dietary intake of at least 30 grams of fiber per day, and of at least 3 grams of PUFAs per day from food, not supplements) at least 4 weeks before surgery


Eligibility criteria: Inclusion Criteria:

* Age between 18-80 years old.
* After clinical diagnosis of CRC (stage I-III), the doctor has recommended and arranged for CRC surgery

Exclusion Criteria:

* Clinical diagnosis of stage IV CRC.
* Current gastrointestinal illness other than gastroesophageal reflux disease or hemorrhoids (such as celiac disease, inflammatory bowel disease, malabsorptive bariatric procedures, etc.).
* Chronic liver or kidney disease.
* History of cardiac disease.
* Positive genetic test for inherited polyposis syndromes (such as familial adenomatous polyps, hereditary non-polyposis colon cancer syndromes, etc).
* Alcoholism or illicit drug use.
* Antibiotic use within the past 2 months.
* Dietary supplement use including pre- or probiotics within the past month.
* History of intestinal cancer, inflammatory bowel disease, celiac disease, or malabsorptive bariatric surgery.
* Inflammatory or connective tissue disease (such as lupus, scleroderma, rheumatoid arthritis, etc.).

Primary outcomes:
measure: Rate of anastomotic leakage
timeFrame: 360 Days from Baseline
measure: Surgical site infection
timeFrame: 360 Days from Baseline
Secondary outcomes:
measure: Change in gut microbiome composition
timeFrame: 360 Days from Baseline
measure: Serum levels of inflammation markers
timeFrame: 360 Days from Baseline
measure: Length of hospitalization after surgery
timeFrame: 360 Days from Baseline
measure: Recurrences of CRC after surgery
timeFrame: 360 Days from Baseline
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Biomedical Research Institute of Murcia (IMIB-Arrixaca)
Study officials:
References: