Clinical trial NCT06919068: Examination of the Large Intestine With Camera Capsule in Patients With Blood Stream Infection With Gut-associated Bacteria
Official title: Colonic Capsule Endoscopy for Screening of Neoplasms in Patients With Anaerobic Bacteremia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Odense University Hospital with anaerobic blood stream infection

Brief 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.


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
* Discharge before result of blood culture
* Transfer to other hospital outside the region

Primary outcomes:
measure: Colorectal cancer and precancerous tumors
timeFrame: 4-8 weeks after hospitalization with anaerobic gut-associated bacteria
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.