ClinicalTrials.gg
RecruitingNCT06919068AB-careUpdated Nov 18, 2025

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

An observational study in Colorectal Cancer (CRC), Colorectal Cancer and Pre-cancer Polyps and Blood Stream Infection, sponsored by Odense University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Odense University Hospital · Observational

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Colorectal Cancer (CRC)
  • Colorectal Cancer and Pre-cancer Polyps
  • Blood Stream Infection
  • Anaerobic Infection
  • Bacteriaemia

Keywords

  • Colorectal Cancer
  • Anaerobic bacteria
  • Bacteria, anaerobic
  • Cancer, colorectal
  • Bacteremia
  • Blood stream infection
  • Colon capsule endoscopy
03

In context

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

This study's planned enrollment of 100 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Able to read and speak Danish

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testColon capsule endoscopy

    PillCam Colon 2

06

What researchers measure

Primary outcomes

  1. Colorectal cancer and precancerous tumors

    Prevalence of colorectal cancer and precancerous tumors using colon capsule endoscopy

    Time frame: 4-8 weeks after hospitalization with anaerobic gut-associated bacteria

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Laupland KB, Edwards F, Furuya-Kanamori L, Paterson DL, Harris PNA. Bloodstream Infection and Colorectal Cancer Risk in Queensland Australia, 2000-2019. Am J Med. 2023 Sep;136(9):896-901. doi: 10.1016/j.amjmed.2023.05.003. Epub 2023 May 23. PubMed 37230400 ↗
  • Justesen US, Nielsen SL, Jensen TG, Dessau RB, Moller JK, Coia JE, Andersen SL, Pedersen C, Gradel KO. Bacteremia With Anaerobic Bacteria and Association With Colorectal Cancer: A Population-based Cohort Study. Clin Infect Dis. 2022 Nov 14;75(10):1747-1753. doi: 10.1093/cid/ciac259. PubMed 35380653 ↗
  • Justesen US, Ellebaek MB, Qvist N, Iachina M, Frimodt-Moller N, Soes LM, Skovgaard S, Lemming L, Samulioniene J, Andersen SL, Dessau RB, Moller JK, Coia JE, Gradel KO. Colorectal cancer and association with anaerobic bacteraemia: A Danish nationwide population-based cohort study. J Infect. 2024 Aug;89(2):106212. doi: 10.1016/j.jinf.2024.106212. Epub 2024 Jul 2. PubMed 38960102 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06919068
Responsible party
Sponsor
First posted
Apr 9, 2025
Start date
Apr 23, 2025
Primary completion
May 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 18, 2025

Study contacts

Charlotte Nielsen Agergaard, MD
Contact
charlotte.agergaard@rsyd.dk
004565414797
Mark Bremholm Ellebæk, Professor
Contact
Mark.Ellebaek1@rsyd.dk
004540880511

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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