NUSSG-01 study

JRCT ID: jRCTs041210057

Registered date:20/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colorectal cancer
• Date of first enrollment: 06/10/2021
• Target sample size: 160
• Study type: Interventional
• Intervention(s): Patients in the synbiotics group intake Super Synbiotics LBG-P while they are waiting for surgery. LBG-P consists of Probiotics packets and Prebiotics packets and patients intake each packet 3 times per day. Patients in the non-synbiotics group do not take LBG-P. Patients are prohibited to intake other synbiotics during the study period.

Outcome(s)

• Primary Outcome: The effects of synbiotics administration on the tumor microenvironment of colorectal cancer (metastatic lesions will also be analyzed if they are simultaneously resected with primary lesion). In detail, the expressions of immune response factors (including PD-L1 expression, counts of intraepithelial lymphocytes), inflammation-associated factors, anti-tumor factors, and tumor proliferation factors will be determined by the immunohistochemistry between synbiotics and non-synbiotics group.

Secondary Outcome

1)Improvement of intestinal microenvironment by synbiotics administration
2)Evaluation of occult-bacterial translocation using pre- and post-operative blood samples
3)Anti-tumorous effects of synbiotics
4)Three-year recurrence free survival after surgery
5)Incidence of adverse events and completion rate of chemotherapy in patients undergoing preoperative chemotherapy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1. Patients who are scheduled to undergo curative resection for primary colorectal cancer. Both patients undergoing upfront surgery without preoperative chemotherapy (Upfront group) and patients undergoing surgery after preoperative chemotherapy (Preoperative chemotherapy group) are going to be included.
2. Patients who are diagnosed as having a primary colorectal cancer by biopsy.
Patients who are scheduled to undergo open, laparoscopic, or robotic surgery for colon cancer.
Patients with distant metastasis or unresectable cancer will also be included.
Age 20-90
Patients who can intake synbiotics.
Patients who agree to buy synbiotics at own expense.
Patients who agreed to participate this study.

Exclude criteria

Patients who are required to undergo emergent surgery.
Additional resection after endoscopic resection
Previous or scheduled radiotherapy for the abdomen
Any systemic chemotherapy within 6 months
Severe mental disorder

Related Information

• Primary Sponsor: Ogura Atsushi