Stool sampling in primary care: A feasibility study
Research type
Research Study
Full title
A feasibility cohort study of recruitment, retention and stool sampling in obese individuals in a primary care setting.
IRAS ID
124700
Contact name
Mark Hull
Contact email
Sponsor organisation
University of Leeds
Research summary
Obesity is associated with inflammation throughout the body including the large bowel. Calprotectin is a protein that is released from white blood cells in response to inflammation. It is readily measured in the stools of individuals who have inflammatory bowel conditions such as Crohn’s disease and ulcerative colitis. An increased incidence of bowel cancer in both inflammatory bowel disease and obesity is well described and, one hypothesis is that inflammation affecting the large bowel in obesity contributes to the increased risk of bowel cancer. Hence, the use of a non-invasive biomarker of obesity related bowel inflammation like faecal calprotectin (FCP) may be useful when determining future bowel cancer risk in obese individuals.
I propose to conduct a pilot study to assess the feasibility of a large primary care study designed to investigate the utility of FCP as a marker of bowel wall inflammation in obesity. I aim to collect information that will inform the design of this study by way of a review of pilot recruitment rates, as well as assessing the acceptability of repeated faecal sampling in an obese primary care cohort of individuals.
In conjunction with the West Yorkshire Primary Care Research Network, suitable individuals will be identified using GP databases. Postal invitations containing a patient information leaflet, consent form and questionnaire will be sent out to eligible individuals. Those who respond will be invited to provide a stool specimen and attend for weight, height), waist and hip circumference measurements at their local GP. This process will be repeated at 3 and 6 months.
Individuals who complete the faecal sampling phase of the study will be invited to attend a focus group discussion about the acceptability of undertaking blood testing and a camera test of their lower bowel, which could form part of the definitive study.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
13/YH/0194
Date of REC Opinion
25 Jul 2013
REC opinion
Further Information Favourable Opinion