Perianal Abscess and Faecal Calprotectin in Preclinical Crohns disease
Research type
Research Study
Full title
Observational Study of Perianal Abscess and Faecal Calprotectin as a Marker in Identifying Preclinical Crohn’s Disease and Terminal Ileal Microbiome Analysis to Further Understand the Aetiopathogenisis of Crohn’s Disease
IRAS ID
328955
Contact name
Anil Thomas George
Contact email
Sponsor organisation
Research And Development Department
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Crohn’s Disease (CD) is a progressive, debilitating and incurable disease with majority of patients presenting before the age of 40 years. CD gets diagnosed usually after the disease has started to irreversibly damage to bowel lining –causing patients to develop symptoms. CD has a silent preclinical phase (phase corresponds to time between the start of the disease and the start of the patient symptoms) lasting years-during which time the disease slowly and silently develops inside the bowel. This study aims to follow-up patients who develop abscesses close to their back passage (perianal abscesses(PA)) as a potential route to identifying preclinical CD – the link between the two conditions is well known. This study also aims to look at the microbes inhabiting the end of the small bowel (terminal ileum) which is supposed to be the cradle where CD is thought to originate and develop. Patients under the age of 40 years who attend hospital with an episode of perianal abscess will be invited to participate. Once confirmed, they will be sent a stool test kit (faecal calprotectin test-which is an internationally accepted test for detecting CD)for completion 6 weeks after the PA episode. They will also be asked to fill in a study questionnaire. If the test is negative the patients will be followed up with similar questionnaires every 6 months for 3 years. If the patients have a positive stool test or have any bowel symptoms, their General Practitioner will be contacted for their referral for a colonoscopy in secondary care-as per National Guidance. At the time of colonoscopy, in addition to normal tissue biopsies, a further tissue sample from the terminal ileum will be taken for microbial analysis to get a detailed bacterial profile. These patients will also be followed up every 6 months for 3 years and then exit the study.
REC name
London - Fulham Research Ethics Committee
REC reference
24/PR/0147
Date of REC Opinion
9 Apr 2024
REC opinion
Further Information Favourable Opinion