Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery

Colorectal Cancer Clinical Trial

Official title:

Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04869956
• Other study ID #: 2021-2-7-HCUVA
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2022
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: Bruno Ramos Molina
• Phone: 968369500
• Email: bruno.ramos[@]imib.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Dietary pattern : High-fiber diet rich in PUFA
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
• Dietary pattern: Standard diet
standard nutritional recommendations

Locations

Country	Name	City	State
Spain	Biomedical Research Institute of Murcia (IMIB-Arrixaca)	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of anastomotic leakage	Number of anastomotic leakage	360 Days from Baseline
Primary	Surgical site infection	Number of site infection	360 Days from Baseline
Secondary	Change in gut microbiome composition	changes in gut microbiota composition by 16S rRNA gene sequencing	360 Days from Baseline
Secondary	Serum levels of inflammation markers	Blood samples will be used to determine markers of inflammation (IL-6, IL-1ß, IL-10 and TNFa), and markers of intestinal permeability (zonulin)	360 Days from Baseline
Secondary	Length of hospitalization after surgery	Number of days	360 Days from Baseline
Secondary	Recurrences of CRC after surgery	Number of recurrences	360 Days from Baseline