Bacteria in stool from IBD patients
Research type
Research Study
Full title
Anonymous analysis of non-pathogenic bacteria in stool, previously collected from adults and adolescents with IBD on iron treatment for calprotectin measurement under separate ethics approval (REC reference: 10/H0504/90)
IRAS ID
185262
Contact name
Ian R. Sanderson
Contact email
Sponsor organisation
Queen Mary, University of London
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
Inflammatory Bowel Disease (IBD) includes two diseases: ulcerative colitis, and Crohn’s disease. Their cause is unknown. Possible aetiologies include immune defects, genetic susceptibility and the environment on the intestine (which includes intestinal bacteria). Since 2010, there has been increased interest in bacteria (termed the microbiota) because we can now identify them using new mechanised analyses.
There is no proven connection between bacteria in the intestine and IBD. However, the diversity of the bacteria is reduced in IBD, and this reduction is greatest when the inflammation is greatest. Whether the changes in the diversity are a cause or a consequence of the inflammation is unknown. A particularly difficult point when following patients longitudinally is understanding if their treatments affect the microbiota in the stool.
Patients with IBD often have iron deficiency anaemia. Consequently many are given oral iron to reverse their anaemia. However, we do not know what changes, if any, oral iron has on the microbiota of the intestine in IBD.
We have frozen stools from 70 patients with IBD before and after iron treatment as part of a previous study (REC number 10/H0504/90; chief investigator Professor Rampton) designed to examine if iron improved the health of patients with IBD. The stools have been stored to measure inflammation (stool calprotectin) under that approval. Approval was not requested in 2010 to examine the microbiota because: analysis of bacteria is not a measurement of disease activity in IBD; mechanised techniques for identifying bacterial species were not available; no data existed on microbial diversity in IBD.
Patients were not asked for consent to examine stool bacteria. Because the current application will not assess any parameters of disease in patients, being a purely exploratory observational study, we are requesting a separate ethical approval. The applicant will have no access to patient identity.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
15/LO/1650
Date of REC Opinion
26 Oct 2015
REC opinion
Favourable Opinion