Intestinal Flora Differences Between Colorectal Cancer Patients and Healthy Individuals

NCT ID: NCT06875648

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-03-01

Brief Summary

This observational case-control study aims to compare the composition of intestinal microbiota between colorectal cancer (CRC) patients and healthy individuals. Fecal samples from 36 CRC patients and 25 healthy controls were analyzed for bacterial abundance. Results indicate significant differences in beneficial, neutral, and harmful bacterial populations between groups, with CRC patients showing reduced beneficial flora (e.g., Lactobacillus) and increased harmful/neutral flora (e.g., Staphylococcus). Further stratification by cancer stage (I-III) revealed progressive dysbiosis with disease progression.

Detailed Description

This observational case-control study investigates the compositional differences in intestinal microbiota between individuals diagnosed with colorectal cancer (CRC) and healthy controls. The study enrolled 36 CRC patients confirmed by histopathology and 25 age- and gender-matched healthy volunteers without gastrointestinal diseases or antibiotic/probiotic use within the preceding three months. Fecal samples were collected from CRC patients at the time of diagnosis and from healthy participants during routine health screenings. Utilizing 16S rRNA sequencing or quantitative PCR, the relative abundance of specific bacterial taxa (e.g., Lactobacillus, Bifidobacterium, Staphylococcus) was quantified to assess dysbiosis patterns. Additionally, the analysis stratified CRC patients by clinical stage (I-III) to explore progressive shifts in microbial communities with disease advancement. The findings aim to elucidate the role of gut microbiota in CRC pathogenesis and provide insights into potential microbiome-based diagnostic or therapeutic strategies.

Conditions

Colorectal Cancer; Gut Microbiota Dysbiosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

CRC Patients

Participants: 36 individuals with histopathologically confirmed colorectal cancer.

Data Source: Archived fecal samples and medical records from patients diagnosed between January 2022 and October 2023.

Inclusion Criteria:

Adults (≥18 years). Newly diagnosed CRC without prior chemotherapy/radiotherapy. Availability of fecal samples collected at diagnosis.

Exclusion Criteria:

Antibiotic/probiotic use within 3 months before sample collection. Concurrent gastrointestinal infections or inflammatory bowel disease. Subgroups: Stratified by clinical stage (I, II, III) based on TNM classification from medical records.

Not applicable (observational study)

Intervention Type: OTHER

Retrospective analysis of gut microbiota in CRC patients vs. healthy controls. No interventions were administered; data were collected from archived samples and medical records.

Healthy Controls

Participants: 25 age- and gender-matched individuals without gastrointestinal diseases or cancer history.

Data Source: Archived fecal samples and health screening records from routine check-ups during the same period.

Inclusion Criteria:

Adults (≥18 years). No history of colorectal polyps, cancer, or chronic gastrointestinal disorders. Normal colonoscopy or fecal occult blood test results.

Exclusion Criteria:

Antibiotic/probiotic use within 3 months before sample collection. Recent acute gastrointestinal symptoms (e.g., diarrhea, constipation).

Not applicable (observational study)

Intervention Type: OTHER

Retrospective analysis of gut microbiota in CRC patients vs. healthy controls. No interventions were administered; data were collected from archived samples and medical records.

Interventions

Not applicable (observational study)

Retrospective analysis of gut microbiota in CRC patients vs. healthy controls. No interventions were administered; data were collected from archived samples and medical records.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults (≥18 years) with histopathologically confirmed colorectal cancer (CRC group)
• Archived fecal sample available from time of CRC diagnosis (prior to treatment)
• Complete clinical records including TNM staging (I-III) for CRC patients
• Age- and gender-matched adults without CRC history (control group)
• Archived fecal sample available from routine health check-ups (control group)

Exclusion Criteria

• Recent antibiotic or probiotic use (within 3 months)
• History of inflammatory bowel disease
• Incomplete medical records
• For controls: history of colorectal cancer, polyps, or chronic gastrointestinal diseases
• For controls: abnormal colonoscopy or fecal occult blood test within the past year

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hansung University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Central Hospital of Guangdong Provincial Nongken

Zhanjiang, Guangdong, China

Countries

China

Other Identifiers

GDMEC-2024-028

Identifier Type: -

Identifier Source: org_study_id