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The Feasibility of Following the Crohn's Diet

Primary Purpose

Crohn Disease, Inflammatory Bowel Diseases, Dietary Modification

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
The Crohn's Diet
Sponsored by
King's College London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King's College London

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
Impact of the Crohn's Diet on BMI
Method: Participants will undergo anthropometric assessment, including weight and height to report BMI.
Impact of the Crohn's Diet on gastrointestinal symptoms
Method: Administer the PRO-2 questionnaire (Khanna et al 2015).
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).

Full Information

First Posted
September 20, 2018
Last Updated
February 25, 2019
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT03691155
Brief Title
The Feasibility of Following the Crohn's Diet
Official Title
The Feasibility of Following the Crohn's Diet
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 8, 2018 (Actual)
Primary Completion Date
December 18, 2018 (Actual)
Study Completion Date
December 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Inflammatory Bowel Diseases, Dietary Modification

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria will include: Adults aged ≥18 years with a diagnosis of Crohn's disease 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). Individuals with a Body Mass Index (BMI) of ≥ 18.5 kg/m2 Individuals able to give informed consent Individuals able to understand and read English Individuals willing to provide consent in this study which involves a dietary change for 14 days Exclusion Criteria will include: Unexplained/unintentional weight loss in the past 6 months Major co-morbidities; for example, diabetes, coeliac disease, major active psychiatric conditions or current eating disorders. 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. Individuals who report to be pregnant or lactating 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Whelan
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE1 9NH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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The Feasibility of Following the Crohn's Diet

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