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Completed

NCT Number: NCT06875648

Intestinal Flora Differences Between Colorectal Cancer Patients and Healthy Individuals

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not applicable (Observational Study)

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.

Primary outcomes

  1. Comparison of Mean Relative Abundance of Intestinal Bacterial Genera between CRC Patients and Healthy Controls

    Time frame: Retrospective analysis of fecal samples collected between January 2021 and March 2025

    The 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.

Sponsors and collaborators

Lead sponsor

Hansung University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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