Bile Acids and Microbiome in Early Colorectal Carcinogenesis

July 8, 2024 updated by: Vilnius University

Bile Acids and Microbiome - Possible Novel Progression Factors and Diagnostic Indicators in Early Colorectal Carcinogenesis

Currently colorectal cancer pathogenesis is mainly explained by the adenoma-carcinoma sequence theory that was proposed more than half a century ago. It mainly focuses on the explanation of genetic mutations that develop throughout the disease course. However, several studies argue that there are also noticeable bile acid metabolism changes and microbiome composition changes within in colorectal cancer patients. However, carcinoma is the final step in the sequence, and prior steps are noticeably less well studied. Thus, the investigators hypothesize, that changes within microbiome and the changes in the urine, serum and gut bile acid composition further leads to the development of colorectal adenoma and subsequent invasive carcinoma.

Adult participants (15 per group) referred for colonoscopy and histologically diagnosed with small (<1cm) adenomas, large (>1cm) adenomas, invasive CRC will be included in the study, as well as 15 healthy controls. Fecal samples will be collected from all participants before bowel preparation. Additionally, urine and serum samples will be collected. Participants will undergo polypectomy, endoscopic mucosal resections, depending on the location, size and histology of the polyp found. During colonoscopy the mucosal biopsy specimens from the lesion and from the healthy bowel -terminal ileum, and colon will be obtained using sterile biopsy forceps. The collected samples will be stored for bile acid and microbiome analysis and for possible further pathology and genetic testing. Healthy participants without visible colorectum pathology during colonoscopy will undergo colon and terminal ileum mucosal sampling.

The investigators plan to evaluate the correlation between the urine and gut microbiome changes and bile acid composition and concentration in adenoma-carcinoma sequence and possibly determine novel bile acids. In addition, fecal, urine and tissue samples will be explored for gut microbiota and bile acid composition changes in healthy and along the adenoma-carcinoma sequence, with the possibility to propose a diagnostic test.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

> 18 years of age, atients that have clinical indications for colonoscopy.

Description

Inclusion Criteria:

- Patients that have clinical indications for colonoscopy

Exclusion Criteria:

  • Pregnancy
  • Immunocompromised
  • Previously diagnosed colorectal diseases
  • Radiotherapy to the pelvis
  • Long term antibiotic use within 6 months
  • Continuous use of proton pump inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
No pathology upon colonoscopy
Small adenoma
< 1cm size polyp upon colonoscopy
Large adenoma
> 1cm size polyp upon colonoscopy
Cancer
Adenocarcinoma upon colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome and bile acid composition correlation to dysplastic changes
Time Frame: Through study completion, an average of 2 years
Microbiome and bile acid composition changes will be detected and correlated with progression of the dysplastic changes within the epithelium of the large bowel.
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bile acid composition in healthy participants
Time Frame: Through study completion, an average of 2 years
Compare bile acid composition of healthy controls to patients with early and advanced adenomas and colorectal cancer, novel bile acid identification that could play a role in the adenoma-carcinoma sequence and identify the diagnostic potential of bile acid composition patterns
Through study completion, an average of 2 years
Bile acid composition in urine, stool and serum
Time Frame: Through study completion, an average of 2 years
Determine the bile acid composition in urine, stool and serum of healthy controls
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vilnius University

Collaborators

Vilnius University Hospital Santaros Klinikos

Investigators

  • Principal Investigator: Tomas Poskus, PhD, Vilnius University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 5, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/5-1587-1047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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