Clinical trial NCT03691155: The Feasibility of Following the Crohn's Diet
Official title: The Feasibility of Following the Crohn's Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Inflammatory Bowel Diseases
Dietary Modification
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Feasibility of following the Crohn's Diet: questionnaire
timeFrame: Throughout the 14-day intervention
Secondary outcomes:
measure: Acceptability of following the Crohn's Diet: questionnaire
timeFrame: Throughout the 14-day intervention and within one week of completing the intervention
measure: Participant compliance to the Crohn's Diet
timeFrame: Throughout the 14-day intervention
measure: Impact of the Crohn's Diet on habitual dietary intake
timeFrame: One week before the intervention and throughout the 14-day intervention
measure: Impact of the Crohn's Diet on BMI
timeFrame: One week before the intervention and within one week of completing the 14-day intervention
measure: Impact of the Crohn's Diet on gastrointestinal symptoms
timeFrame: One week before the intervention and within one week of completing the 14-day intervention
measure: Impact of the Crohn's Diet on perceived disease control
timeFrame: One week before the intervention and within one week of completing the 14-day intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Kevin Whelan
role: PRINCIPAL_INVESTIGATOR
References: