Crohn's disease and body composition.V1
Research type
Research Study
Full title
A longitudinal study of the relationship between body composition and dietary intake on remission rates in patients with Crohn’s disease initiating biological agents.
IRAS ID
273925
Contact name
Hanan Bukhari
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
1 years, 4 months, 28 days
Research summary
This study seeks to carry-out an exploratory assessment using a longitudinal cohort design to assess the relationship between body composition and dietary intake on the rates of remission in patients who have been diagnosed with Crohn’s disease and starting biological agents treatment. 120 participants will be recruited from three NHS hospital sites in Manchester and the Northern Care Alliance. The inclusion criteria are adult patient (over 18 years) with active Crohn’s disease, defined as Harvey Bradshaw Index ≥7, never received biological treatment previously, and able to provide written informed consent. Participants data will be collected at three different intervals, at baseline, after 3 months and after 6 months. The primary outcome will be remission measured by Harvey Bradshaw index and body composition and muscle mass will be assessed using bioelectrical impedance analysis, handgrip strength, and if available, computed tomography scans. The participants’ dietary intake will be estimated by food records, using an online dietary assessment tool Intake24. After the last follow up appointment, a sample of participants will be invited to participate in the qualitative part of this study. The aim of the qualitative interviews is to identify the patients perspectives about diet, weight and muscle strength before and after they started biological agents treatment. Approximately 20 patients will be interviewed until no new themes are being generated by the interviews using a purposive sampling approach.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
20/ES/0014
Date of REC Opinion
17 Feb 2020
REC opinion
Further Information Favourable Opinion