Identifying Nutritional Targets in Crohn's Disease (INTICO-2)
Research type
Research Study
Full title
Identifying nutritional targets in Crohn’s disease: Cross-sectional study (INTICO-2)
IRAS ID
283090
Contact name
Sharon Davies-Dear
Contact email
Sponsor organisation
University Hospital Southampton NHS trust R&D
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
We are looking to explore micronutrient status as it relates to fatigue in people with Crohn's Disease during disease remission. There is a significant burden of excess fatigue for individuals with Crohn's Disease throughout their disease course with an estimated 80% affected when their disease is active and 40-45% during remission. Whilst treatments to induce and maintain remission from intestinal inflammation have progressed, the evidence for the causes of and effective treatments for fatigue in Crohn's Disease is limited.
A poor micronutrient state may occur with dietary restrictions and chronic inflammation which are both known features within the Crohn's Disease population. A poor nutritional state may reduce resilience, capacity for work, physical and mental well-being, yet the specific relationship between micronutrient state and health-related quality of life (HR-Qol) in Crohn's Disease is not known.
INTICO-1 explored nutritional status in 24 individuals with Crohn's Disease in remission. The study revealed that poor micronutrient state was common in the group and that both this and subjective measures of fatigue (as assessed by patient reported outcome measures (PROMs)) could be improved with a short period of a nutritionally complete diet.
This study is seeking to explore the micronutrient analytes of interest across a larger cohort, together with a fatigue specific PROM and a measure of functional capacity to explore the inter-relationship between micronutrient state and fatigue. This will be used to identify subjects for, and inform the design, of an interventional nutritional study to treat fatigue in Crohn's Disease.REC name
West of Scotland REC 3
REC reference
20/WS/0117
Date of REC Opinion
3 Sep 2020
REC opinion
Favourable Opinion