Examination of the Large Intestine With Camera Capsule in Patients With Blood Stream Infection With Gut-associated Bacteria (AB-care)

November 17, 2025 updated by: Odense University Hospital

Colonic Capsule Endoscopy for Screening of Neoplasms in Patients With Anaerobic Bacteremia

The goal of this observational study is to diagnose colorectal cancer or precancerous tumors in participants over the age of 18 hospitalized with blood stream infection with anaerobic gut-associated bacteria. The main question it aims to answer is:

• How prevalent is cancer and precancerous tumors in the large intestines and rectum in patients with anaerobic bacteremia? Participants will be offered an examination using colon capsule endoscopy 4-8 weeks after discharge.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

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

  • Denmark
      • Odense, Denmark, 5000
        • Recruiting
        • Odense University Hospital
        • Contact:

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

Patients admitted to Odense University Hospital with anaerobic blood stream infection.

Patients who are discharged before result of blood culture with anaerobic gut-associated bacteria, will be contacted by letter and offered participation in the study.

Description

Inclusion Criteria:

  • Older than 18 years
  • Blood culture with growth of one or more of the following bacterial genera Bacteroides, Clostridium, Filifactor, Fusobacterium, Gemella, Granulicatella, Parvimonas, Peptostreptococcus, Prevotella, Solobacterium, Peptoniphilus, Ruminococcus, Finegoldia and Streptococcus.
  • Able to provide oral and written informed consent
  • Able to read and speak Danish

Exclusion Criteria:

  • Prior colorectal cancer diagnosis
  • History of stenosis of the gastrointestinal tract
  • Previous treatment of inflammatory bowel disease
  • Previous major surgery of the gastrointesinal tract (e.g. gastric bypass)
  • Colostomy
  • Pacemaker/ICD
  • Pregnancy or breastfeeding
  • Allergies to the bowel preparation regimen
  • Severe kidney disease
  • Focus of infection in skin and soft tissue or outside the truncus (e.g. decubitus, diabetic foot ulcer)
  • Tumor in the colon or rectum at diagnostic imaging
  • Transfer to other hospital outside the region

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colorectal cancer and precancerous tumors
Time Frame: 4-8 weeks after hospitalization with anaerobic gut-associated bacteria
Prevalence of colorectal cancer and precancerous tumors using colon capsule endoscopy
4-8 weeks after hospitalization with anaerobic gut-associated bacteria

Collaborators and Investigators

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

Sponsor

Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 23, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEK_ID_S-20240090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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