The Feasibility of Following the Crohn's Diet

Crohn Disease Clinical Trial

Official title:

The Feasibility of Following the Crohn's Diet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691155
• Other study ID #: LRS-17/18-7313
• Status: Completed
• Phase: N/A
• Start date: July 8, 2018
• Est. completion date: December 18, 2018

Study information

• Verified date: February 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Dietary Modification
• Inflammatory Bowel Diseases

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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