INTICO study
Research type
Research Study
Full title
INTICO study: Identifying Nutritional Targets In CrOhn's disease
IRAS ID
215871
Contact name
Martin McDonnell
Contact email
Sponsor organisation
University Hospital Southampton NHS trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
We are looking to identify targets for nutritional therapy in people with Crohn’s disease (CD). Crohn’s Disease affects up to 100’000 people in the UK and its prevalence is increasing. We know that at diagnosis, many patients with CD are underweight and that throughout its course people can become deficient in certain nutrients. Nutritional therapy can be used as a treatment for CD in certain situations, but the specific requirements of those with CD and the extent to which dietary variation contributes to and confounds studies that attempt to better understand this is not known.
This study will provide a short period of controlled diet to a group of patients with CD that is currently in remission. Using body measurements and analysis of blood, urine and stool samples, we will assess in detail participants’ nutritional status before and after a week of standardised feeding, then again after they have returned to their normal diet. At these time points we aim to establish and compare the variability that exists between patients, and whether it can be reduced by the controlled diet.
The study will also aim to establish what, if any nutritional deficits may remain over and above this period of controlled feeding to better understand the specific requirements of people with CD. These identified deficits can be used as a preliminary to potentially inform future targeted nutritional interventions.
We will invite patients from the IBD clinic and the patient database at Southampton Hospitals. After screening and consenting interested patients, they will come for assessments and samples before and after the week of standard feeding, then again for a final assessment 2 weeks afterwards. We aim to recruit 25 people and have completed the study within 6-8 months.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0065
Date of REC Opinion
15 Mar 2018
REC opinion
Further Information Favourable Opinion