NCT02426567

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 27, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

April 17, 2015

Last Update Submit

June 12, 2016

Conditions

Crohn's DiseaseDietary Modification

Keywords

Crohn's DiseaseExclusive Enteral NutritionDietary TreatmentGut microbiota

Outcome Measures

Primary Outcomes (2)

  • Gut Bacterial Composition

    Gut microbiota composition measured by 16S rRNA gene amplicon sequencing, whole genome shotgun metagenomics and qPCR of selective bacterial species previously implicated in the onset of CD (e.g. Escherichia coli, Faecalibacterium prausnitzii, Bifidobacterium spp)

    12 months

  • Gut Bacterial Metabolites

    Gut microbiota metabolic activity as a measure of short chain fatty acids, hydrogen sulfide, lactate, ammonia and pH levels

    12 months

Secondary Outcomes (1)

  • Dietary Intake

    12 months

Study Arms (2)

Healthy Adult Participants A

EXPERIMENTAL

Participants who will get two interventional diets, for 7 days each, but allocated to start with Exclusive Enteral Nutrition (EEN)

Other: Exclusive Enteral Nutrition (EEN)Other: Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet)

Healthy Adult Participants B

EXPERIMENTAL

Participants who will get two interventional diets, for 7 days each, but allocated to start with Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet)

Other: Exclusive Enteral Nutrition (EEN)Other: Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet)

Interventions

Exclusive Enteral Nutrition (EEN)OTHER

One week course of an isocaloric exclusive milk-based diet

Healthy Adult Participants AHealthy Adult Participants B
Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet)OTHER

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

Healthy Adult Participants AHealthy Adult Participants B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult people
  • Normal weight (Body Mass Index: 18-25kg/m\^2)
  • Stable weight the past month

You may not qualify if:

  • Acute or chronic illness (defined as illness which requires regular visits to health services)
  • Positive or negative energy balance (recent weight gain or loss, ±2 Kg the past month)
  • History of gut surgery
  • Use of antibiotics or steroids the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine, University of Glasgow / New Lister Building, Glasgow Royal Infirmary

Glasgow, G312ER, United Kingdom

Location

Related Publications (1)

  • Svolos V, Hansen R, Nichols B, Quince C, Ijaz UZ, Papadopoulou RT, Edwards CA, Watson D, Alghamdi A, Brejnrod A, Ansalone C, Duncan H, Gervais L, Tayler R, Salmond J, Bolognini D, Klopfleisch R, Gaya DR, Milling S, Russell RK, Gerasimidis K. Treatment of Active Crohn's Disease With an Ordinary Food-based Diet That Replicates Exclusive Enteral Nutrition. Gastroenterology. 2019 Apr;156(5):1354-1367.e6. doi: 10.1053/j.gastro.2018.12.002. Epub 2018 Dec 11.

    PMID: 30550821DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Konstantinos Gerasimidis, BSc MSc PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Clinical Nutrition

Study Record Dates

First Submitted

April 17, 2015

First Posted

April 27, 2015

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

June 14, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)