The Feasibility of Following the Crohn's Diet

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 20, 2018

First Posted Date ^ICMJE

October 1, 2018

Last Update Posted Date

October 1, 2018

Actual Study Start Date ^ICMJE

July 8, 2018

Estimated Primary Completion Date

February 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Feasibility of following the Crohn's Diet: questionnaire[ Time Frame: 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Acceptability of following the Crohn's Diet: questionnaire[ Time Frame: 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).
Participant compliance to the Crohn's Diet[ Time Frame: 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 habitual dietary intake[ Time Frame: 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[ Time Frame: 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.
Impact of the Crohn's Diet on gastrointestinal symptoms[ Time Frame: 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).
Impact of the Crohn's Diet on perceived disease control[ Time Frame: 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).

Descriptive Information

Brief Title ^ICMJE

The Feasibility of Following the Crohn's Diet

Official Title ^ICMJE

The Feasibility of Following the Crohn's Diet

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

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

Condition ^ICMJE

Intervention ^ICMJE

Other: The Crohn's Diet
All recruited participants will be educated on the Crohn's Diet and instructed to adhere to the study diet for 14 days.

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

March 1, 2019

Estimated Primary Completion Date

February 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United Kingdom

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

King's College London

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Kevin Whelan King's College London

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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