The Feasibility of Following the Crohn's Diet

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Dietary Modification
• Intervention / Treatment: Other: The Crohn's Diet

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9NH
    • King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria will include:

1. Adults aged ≥18 years with a diagnosis of Crohn's disease
2. Stable Crohn's disease (as defined as self-reported: no change in Crohn's disease medication in the last 3 months; no Crohn's disease surgery in the last 6 months; no hospital admissions related to Crohn's disease in the last 6 months; no new perianal Crohn's disease in the last 6 months).
3. Individuals with a Body Mass Index (BMI) of ≥ 18.5 kg/m2
4. Individuals able to give informed consent
5. Individuals able to understand and read English
6. Individuals willing to provide consent in this study which involves a dietary change for 14 days

Exclusion Criteria will include:

1. Unexplained/unintentional weight loss in the past 6 months
2. Major co-morbidities; for example, diabetes, coeliac disease, major active psychiatric conditions or current eating disorders.
3. Current Crohn's disease therapy with any of the following: corticosteroids, exclusive or partial enteral nutrition (liquid nutrition), and any participants prescribed oral nutrition supplements for nutrition support.
4. Individuals who report to be pregnant or lactating
5. Individuals with specific, complex dietary needs (based on the dietitian's judgment), such as multiple food allergies, in which the additional burden of the Crohn's Diet would pose a nutrition risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of following the Crohn's Diet: questionnaire	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.	Throughout the 14-day intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: King's College London
• Investigators: Principal Investigator: Kevin Whelan, King's College London

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2018
• Primary Completion (Actual): December 18, 2018
• Study Completion (Actual): December 18, 2018

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: LRS-17/18-7313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No