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

NCT06919068 | Recruiting

• 1 other identifier: VEK_ID_S-20240090
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Colorectal cancer and precancerous tumors

  Prevalence of colorectal cancer and precancerous tumors using colon capsule endoscopy

  4-8 weeks after hospitalization with anaerobic gut-associated bacteria

Interventions

Colon capsule endoscopy DIAGNOSTIC_TEST

PillCam Colon 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Bacteremia

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Charlotte Nielsen Agergaard, MD

CONTACT

004565414797; charlotte.agergaard@rsyd.dk

Mark Bremholm Ellebæk, Professor

CONTACT

004540880511; Mark.Ellebaek1@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: April 23, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-09

Locations

DK (1)