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NCT Number: NCT03691155

The Feasibility of Following the Crohn's Diet

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.

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Key information

Conditions

Crohn Disease Dietary Modification Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College London

London, SE1 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

will include:

  • 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

Exclusion criteria

will include:

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of following the Crohn's Diet: questionnaire

    Time frame: 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 outcomes

  1. Acceptability of following the Crohn's Diet: questionnaire

    Time frame: 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).

  2. Participant compliance to the Crohn's Diet

    Time frame: 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.

  3. Impact of the Crohn's Diet on habitual dietary intake

    Time frame: 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.

  4. Impact of the Crohn's Diet on BMI

    Time frame: 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.

  5. Impact of the Crohn's Diet on gastrointestinal symptoms

    Time frame: 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).

  6. Impact of the Crohn's Diet on perceived disease control

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 1, 2018
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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