NCT04225689

Brief Summary

Crohn's disease (CD) is a chronic inflammatory condition with phases where the disease is active and other, where there are no symptoms. Exclusive enteral nutrition (EEN), a liquid only diet without allowance of any extra food, is the main treatment for children with active CD. However, when children stop the liquid diet and return to their normal diet, most of them will experience an increase in their gut inflammation, mostly without symptoms initially. The aim of this study is to investigate this phenomenon by exploring if diet and gut bacteria play a role. Furthermore, the investigators aim to test whether a new, ordinary food-based diet, called the Crohn's Disease TReatment with EATing (CD-TREAT) diet can help control gut inflammation during the early food reintroduction phase, after EEN completion, compared to an unrestricted, free diet.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

December 20, 2019

Last Update Submit

July 20, 2020

Conditions

Crohn Disease

Keywords

food reintroductiondietary interventiondietary triggersfaecal calprotectinCD-TREATExclusive enteral nutrition

Outcome Measures

Primary Outcomes (1)

  • Colonic inflammation

    Comparison of faecal calprotectin levels between the intervention (CD-TREAT) and the control (unrestricted diet) group

    Baseline to 21 days post EEN completion

Secondary Outcomes (5)

  • Diet and faecal microbiome

    Baseline to 21 days post EEN completion

  • Diet and faecal metabolome

    Baseline to 21 days post EEN completion

  • Crohn's Disease activity score

    Baseline to 21 days post EEN completion

  • Blood inflammatory markers

    Baseline to 21 days post EEN completion

  • Quality of life

    Baseline to 21 days post EEN completion

Study Arms (2)

CD-TREAT diet

EXPERIMENTAL

Solid food-based dietary intervention replicating composition of exclusive enteral nutrition (EEN). Daily for a maximum of 21 days. Individualised diet based on energy requirements and physical activity levels.

Other: CD-TREAT diet

Unrestricted diet

NO INTERVENTION

Free, unrestricted diet. Daily for a maximum of 21 days.

Interventions

CD-TREAT dietOTHER

Dietary intervention

CD-TREAT diet

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Newly diagnosed or relapsing patients with active CD, who have shown clinical improvement by the 4th week of EEN treatment

You may not qualify if:

  • Administration of another induction treatment (e.g. corticosteroids, biologic agents).
  • Lack of clinical improvement with EEN treatment, as assessed by the clinical team.
  • Enrolment in other studies investigating the efficacy of novel therapies for maintenance or induction of remission.
  • Patients or families unable to provide written consent for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Hospital Crosshouse

Crosshouse, KA2 0BE, United Kingdom

NOT YET RECRUITING

Royal Hospital for Sick Children

Edinburgh, EH9 1LF, United Kingdom

NOT YET RECRUITING

Royal Hospital for Children

Glasgow, G51 4TF, United Kingdom

RECRUITING

Forth Valley Royal Hospital

Larbert, FK5 4WR, United Kingdom

NOT YET RECRUITING

University Hospital Wishaw

Wishaw, ML2 0DP, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Richard K Russell, MBChB, MRCP, MRCPCH, PhD

    NHS Greater Glasgow and Clyde

    PRINCIPAL INVESTIGATOR

  • Konstantinos Gerasimidis, PhD, MSc, BSc, FHEA

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantinos Gkikas, MSc, Bsc

CONTACT

07759451611k.gkikas.1@research.gla.ac.uk

Richard K Russell, MBChB, MRCP, MRCPCH, PhD

CONTACT

01414516543richardrussell@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Electronic random block-size randomisation will be performed by a researcher not involved in study recruitment. Allocation to study arm will be revealed to participants after provision of informed consent.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2019

First Posted

January 13, 2020

Study Start

January 10, 2020

Primary Completion

January 1, 2023

Study Completion

February 1, 2024

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Participants will be asked to provide written consent for their anonymised data to be made available to public data repositories.

Locations

GB(5)