Crohn Disease, Dietary Modification, Inflammatory Bowel Diseases
Conditions
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.
Interventions
OTHERThe 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.
Sponsors
King's College London
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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). |
| 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). |
| 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. |
Countries
United Kingdom
Outcome results
None listed