The Feasibility of Following the Crohn's Diet

Not Applicable

Completed

• Conditions: Crohn Disease; Inflammatory Bowel Diseases; Dietary Modification

• Registration Number: NCT03691155
• Lead Sponsor: King's College London

Brief Summary

A research team from King's College London are investigating how diet can be used as a treatment for Crohn's disease. The investigators have designed a new diet and eventually wish to test whether the diet can be used to manage Crohn's disease and reduce gut inflammation. Before doing this, the investigators need to find out how practical it is for people to follow the diet for 14 days by conducting this 'feasibility' study. A feasibility study is a small study that aims to highlight any issues before informing the design of a larger research trial.

The diet the investigators have designed is called the Crohn's Diet. The evidence for this diet is based on recent research which suggests that certain food ingredients may be involved in triggering gut inflammation.

The study's primary aim is to assess the practicalities of following the Crohn's Diet. It will also assess compliance to the Crohn's Diet and if following it changes the nutritional balance from the normal diet.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-08
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-10-01
• Primary Completion: 2018-12-18
• Study Completion: 2018-12-18
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of following the Crohn's Diet: questionnaire	Throughout the 14-day intervention	Method: Collation of participant feedback during the Crohn's Diet and administer diet feasibility questionnaire. This questionnaire uses an adapted Education Method Usability Scale (Bangor et al. 2008) ('strongly agree' to 'strongly disagree' style scale) and open questions.

Secondary Outcome Measures

Name	Time	Method
Impact of the Crohn's Diet on gastrointestinal symptoms	One week before the intervention and within one week of completing the 14-day intervention	Method: Administer the PRO-2 questionnaire (Khanna et al 2015).
Acceptability of following the Crohn's Diet: questionnaire	Throughout the 14-day intervention and within one week of completing the intervention	Method: Administer questionnaires on diet acceptability, including the Food-Related Quality of Life in Inflammatory Bowel Disease questionnaire (Hughes et al 2016).
Impact of the Crohn's Diet on habitual dietary intake	One week before the intervention and throughout the 14-day intervention	Method: 7-day food diaries to compare nutrient intake and explore changes in dietary patterns.
Impact of the Crohn's Diet on BMI	One week before the intervention and within one week of completing the 14-day intervention	Method: Participants will undergo anthropometric assessment, including weight and height to report BMI.
Participant compliance to the Crohn's Diet	Throughout the 14-day intervention	Method: Dietitian monitoring of compliance during the trial. A 7-day food diary will quantify compliance alongside a questionnaire which explores reasons for potential non-compliance.
Impact of the Crohn's Diet on perceived disease control	One week before the intervention and within one week of completing the 14-day intervention	Method: Administer questionnaires, including the Inflammatory Bowel Disease Control-8 questionnaire (IBD-C-8) (Bodger et al. 2013).

Trial Locations

Locations (1)

King's College London; 🇬🇧 London, United Kingdom