Menu
Recruiting NCT06919068

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Colon capsule endoscopy.
Who it may be relevant to
Registry conditions: Colorectal Cancer (CRC), Colorectal Cancer and Pre-cancer Polyps, Blood Stream Infection, Anaerobic Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Diagnostic test Colon capsule endoscopy
    PillCam Colon 2

Primary outcome measures

  • Colorectal cancer and precancerous tumors [Time frame: 4-8 weeks after hospitalization with anaerobic gut-associated bacteria]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Odense University Hospital — Odense

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. PMID 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. PMID 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. PMID 38960102

Identifiers

NCT: NCT06919068 · VEK_ID_S-20240090

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗