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NUSSG-01 study

Investigation for the effects of synbiotics on the tumor microenvironment of colon cancer (NUSSG-01study) - Nagoya University Synbiotics Study Group-01 study (NUSSG-01study)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041210057
Enrollment
160
Registered
2021-08-20
Start date
2021-10-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer Colorectal cancer

Interventions

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

Sponsors

Ogura Atsushi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactAtsushi Ogura

Nagoya University

aogu613@med.nagoya-u.ac.jp+81-52-744-2218

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026