Clinical trial NCT06875648: Intestinal Flora Differences Between Colorectal Cancer Patients and Healthy Individuals
Official title: Intestinal Flora Differences Between Colorectal Cancer Patients and Healthy Individuals: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer; Gut Microbiota Dysbiosis
Keywords: Colorectal Neoplasms (MeSH)
Gastrointestinal Microbiome (MeSH)
Dysbiosis (MeSH)
Microbial Biomarkers
Lead sponsor: Hansung University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective case-control study of 36 CRC patients (stages I-III, diagnosed 2022-2023) and 25 healthy controls from Central Hospital, Zhanjiang, China. CRC group: pre-treatment fecal samples, TNM staging. Control group: age/gender-matched, no GI diseases, normal colonoscopy/fecal tests. Exclusions: antibiotic/probiotic use (past 3 months), inflammatory bowel disease, incomplete records.

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.

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

Primary outcomes:
measure: Comparison of Mean Relative Abundance of Intestinal Bacterial Genera between CRC Patients and Healthy Controls
timeFrame: Retrospective analysis of fecal samples collected between January 2021 and March 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Zhanjiang
country: China
facility: Central Hospital of Guangdong Provincial Nongken
state: Guangdong
Study officials:
References: