Clinical trial · Observational
FIT in Diverticulitis
Use of Faecal Biomarkers After Acute Diverticulitis: Can They Risk Stratify for Colorectal Cancer?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background and study aims Diverticular disease or diverticulosis is a benign disease of the colon. Diverticulae are pockets of bowel wall which protrude through weaknesses in the muscular wall of the colon. The mechanisms leading to their formation remains unclear and is likely a complex interaction of multiple factors. For the majority of people these pockets are incidental findings they can become inflamed which is called diverticulitis. The main aim of this study is to see if a faecal samples, which will be tested for hidden blood content with a faecal immunochemical test for haemoglobin (FIT), could be used as an alternative to currently used follow-up investigations for patients who have an episode of acute diverticulitis confirmed on a computerised tomography (CT) scan. These are colonoscopy, sigmoidoscopy or a special CT called CT colonoscopy. The investigators will also be testing faecal calprotectin which is a marker of bowel inflammation and an assessment of the microbes that live in the bowel to see if this will provide further insights into the diagnosis and treatment of diverticulitis. Who can participate? All patients 18 or over admitted to a participating hospital with acute diverticulitis confirmed on a CT scan and who planned to have one of the currently used follow-up investigations are eligible. What does the study involve? The study will involve participants taking three stool (faecal) samples using faecal testing kits posted to participants. One is as close to their first solid stool after diagnosis as possible, the others are at 3 weeks after diagnosis and then 6 weeks after diagnosis. What are the possible benefits and risks of participating? There are no risks of participating. The investigators hope to demonstrate that a negative FIT test for patients after acute diverticulitis will be able to exclude a bowel cancer and prevent the majority of future patients having invasive and time consuming tests. There no additional benefit for participants for their current episode, as they will still need to have these tests. Where is the study run from? Royal Surrey County Hospital When is the study starting and how long is it expected to run for? 09/10/2023-30/09/2024 Who is funding the study? The study is being funded by MATTU (Minimal Access Therapy Training Unit), GUTS (GUTS - Fighting Bowel Cancer) and NHIR (National Institute for Health and Care Research). Who is the main contact? James Norman, On the study email rsch.colorectalDfitstudy@nhs.net
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Diverticulitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Faecal immunochemical test for haemoglobin, faecal calprotectin, faecal microbiome | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study cohort
- description
- In addition to standard of care, three faecal samples will be obtained. On as soon as possible after diagnosis, one at three weeks post diagnosis and one at six.
- interventionNames
- Diagnostic Test: Faecal immunochemical test for haemoglobin, faecal calprotectin, faecal microbiome
Primary outcomes (1)
- measure
- Colorectal Cancer
- timeFrame
- Dependant on timing of investigation but expected 6-12 weeks
- description
- Diagnosis or absence of colorectal cancer on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
Secondary outcomes (5)
- measure
- High risk adenoma
- timeFrame
- Dependant on timing of investigation but expected 6-12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Computerised tomography diagnosis of acute diverticulitis * Participants capable of giving informed consent * Aged ≥ 18 years * Clinical decision for colonoscopy, flexible sigmoidoscopy or CT colonoscopy follow-up after diverticulitis diagnosis Exclusion Criteria: * Paediatric patients (\<18 years) * Not provided at least 1 faecal sample * Unable to/unwilling to provide informed consent * Withdrawal of consent for inclusion in study * Previous pan-proctocolectomy, subtotal colectomy surgery, or presence of stoma * Currently being treated for colorectal cancer * Mental health illness limiting compliance * Treated in hospital with colonic resection * Did not have colonoscopy, flexible sigmoidoscopy or CT colonoscopy
References
Publications (0)
Data not yet available