NCT03691155

The Feasibility of Following the Crohn's Diet

Completed NA Last updated 26 February 2019

What this trial tests

NA trial testing The Crohn's Diet in Crohn Disease in 20 participants. Completed in 18 December 2018.

Timeline

8 July 2018

Primary endpoint
18 December 2018

18 December 2018

Quick facts

Lead sponsor	King's College London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	single
Primary purpose	other
Enrollment	20
Start date	8 July 2018
Primary completion	18 December 2018
Estimated completion	18 December 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• The Crohn's Diet

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →
• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
• Dietary Modification — all drugs for Dietary Modification →

Sponsor

King's College London

Who can join

18 and older, any sex, with Crohn Disease or Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Emulsifiers Impact Colonic Length in Mice and Emulsifier Restriction is Feasible in People with Crohn's Disease.
   Sandall AM, Cox SR, Lindsay JO, Gewirtz AT, et al · · 2020 · cited 46× · PMID 32942699 · DOI 10.3390/nu12092827