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

NCT ID: NCT06919068

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-23

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Colon capsule endoscopy

PillCam Colon 2

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Charlotte Nielsen Agergaard, MD

Role: CONTACT

004565414797

Mark Bremholm Ellebæk, Professor

Role: CONTACT

004540880511

Facility Contacts

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Mark Bremholm Ellebæk, Professor

Role: primary

004540880511

References

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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.

Reference Type BACKGROUND
PMID: 37230400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35380653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38960102 (View on PubMed)

Other Identifiers

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VEK_ID_S-20240090

Identifier Type: -

Identifier Source: org_study_id

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