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The Impact of "Crohn's Disease-TReatment-with-EATing" Diet and Exclusive Enteral Nutrition on Healthy Gut Bacteria

NCT02426567 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2016-06-14

No results posted yet for this study

Summary

Current evidence suggests that the gut microbiota and dietary influences are as important as genetics in the aetiology of Crohn's disease (CD). We have recently shown that disease improvement, following treatment with Exclusive Enteral Nutrition (EEN), coincided with changes in the gut microbiota.

The main purposes of this study are: a) to explore whether the gut microbiota changes we observed in this previous study in children with CD during EEN are disease specific or not, and b) to develop a novel food-based diet (Crohn's Disease TReatment-with-EATing/CD-TREAT diet) which will induce changes to the metabolic activity and bacterial composition of the gut microbiota of healthy people, similar to those seen on EEN, the first-line treatment for active paediatric CD.

This study will produce high quality scientific evidence to move the CD-TREAT diet towards a preliminary clinical trial in patients with CD which is currently inappropriate and unethical to carry out in people with active CD undertaking contemporary medical treatment.

Conditions

Interventions

OTHER

Exclusive Enteral Nutrition (EEN)

One week course of an isocaloric exclusive milk-based diet

OTHER

Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet)

One week course of an isocaloric, exclusion food-based diet

Sponsors & Collaborators

  • University of Glasgow

    lead OTHER

Principal Investigators

  • Konstantinos Gerasimidis, BSc MSc PhD · University of Glasgow

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02426567 on ClinicalTrials.gov