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Intestinal Flora Differences Between Colorectal Cancer Patients and Healthy Individuals

Intestinal Flora Differences Between Colorectal Cancer Patients and Healthy Individuals: A Case-Control Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06875648
Enrollment
61
Registered
2025-03-13
Start date
2021-01-01
Completion date
2025-03-01
Last updated
2025-03-18

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

Conditions

Colorectal Cancer; Gut Microbiota Dysbiosis

Keywords

Colorectal Neoplasms (MeSH), Gastrointestinal Microbiome (MeSH), Dysbiosis (MeSH), Microbial Biomarkers

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.

Interventions

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

Sponsors

Hansung University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of Mean Relative Abundance of Intestinal Bacterial Genera between CRC Patients and Healthy ControlsRetrospective analysis of fecal samples collected between January 2021 and March 2025The primary metric is the mean relative abundance of specific intestinal bacterial genera (e.g., Lactobacillus, Bifidobacterium, Staphylococcus). Quantitative comparison will be performed between CRC patients and healthy controls using data obtained from fecal samples via 16S rRNA sequencing or qPCR. This is a retrospective analysis of samples collected between January 2021 and March 2025.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026