Colorectal Cancer (CRC)AB-careNCT06919068
Examination of the Large Intestine With Camera Capsule in Patients With Blood Stream Infection With Gut-associated Bacteria
An observational study of Colorectal Cancer (CRC) and Colorectal Cancer and Pre-cancer Polyps, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer (CRC), Colorectal Cancer and Pre-cancer Polyps, Blood Stream Infection
- What is being tested?
- Colon capsule endoscopy
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Apr 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, 5000
Mark Bremholm Ellebæk, Professor, 004540880511, Mark.Ellebaek1@rsyd.dk
About this study
Official title: Colonic Capsule Endoscopy for Screening of Neoplasms in Patients With Anaerobic Bacteremia
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
- Being tested
- Colon capsule endoscopy
- Keywords
- Colorectal Cancer, Anaerobic bacteria, Bacteria, anaerobic, Cancer, colorectal, Bacteremia, Blood stream infection, Colon capsule endoscopy
- Medical subject headings
- Colorectal Neoplasms, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon capsule endoscopyDiagnostic test
PillCam Colon 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer and precancerous tumors
Prevalence of colorectal cancer and precancerous tumors using colon capsule endoscopy
Measured: 4-8 weeks after hospitalization with anaerobic gut-associated bacteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start23 Apr 2025
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919068
- Sponsor's protocol ID
- VEK_ID_S-20240090
- Acronym
- AB-care
- Status last verified
- Sep 2025
- First submitted
- 2 Apr 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 37230400Justesen 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 35380653Justesen 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonic Capsule Endoscopy for Screening of Neoplasms in Patients With Anaerobic Bacteremia
- ClinicalTrials.gov ID
- NCT06919068
- Acronym / sponsor ID
- AB-care / VEK_ID_S-20240090
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colon capsule endoscopyPillCam Colon 2 | Diagnostic test | – |
Primary outcome
Colorectal cancer and precancerous tumors
Time frame: 4-8 weeks after hospitalization with anaerobic gut-associated bacteria
Prevalence of colorectal cancer and precancerous tumors using colon capsule endoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 37230400Laupland 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.
- Background: PubMed 35380653Justesen 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.
- Background: PubMed 38960102Justesen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer (CRC) and Colorectal Cancer and Pre-cancer Polyps, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Nielsen Agergaard, MD (004565414797, charlotte.agergaard@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal cancer and precancerous tumors (time frame: 4-8 weeks after hospitalization with anaerobic gut-associated bacteria). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06919068, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.