The Feasibility of Following the Crohn's Diet

NCT03691155 | Completed DMC

• 1 other identifier: LRS-17/18-7313
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Dietary Modification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Acceptability of following the Crohn's Diet: questionnaire

  Throughout the 14-day intervention and within one week of completing the intervention

• Participant compliance to the Crohn's Diet

  Throughout the 14-day intervention

• Impact of the Crohn's Diet on habitual dietary intake

  One week before the intervention and throughout the 14-day intervention

• Impact of the Crohn's Diet on BMI

  One week before the intervention and within one week of completing the 14-day intervention

• Impact of the Crohn's Diet on gastrointestinal symptoms

  One week before the intervention and within one week of completing the 14-day intervention

Interventions

The Crohn's Diet OTHER

All recruited participants will be educated on the Crohn's Diet and instructed to adhere to the study diet for 14 days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College London

London, SE1 9NH, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Kevin Whelan

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 1, 2018
• Study Start: July 8, 2018
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)