The Feasibility of Following the Crohn's Diet

King's College London

Status: Completed

Conditions: Dietary Modification; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: The Crohn's Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03691155

LRS-17/18-7313

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind