NCT02341248

Brief Summary

Exclusive Enteral Nutrition (EEN) is the liquid diet given to children with active Crohn's Disease (CD). EEN has previously been shown to induce changes in major bacterial metabolites and dominant bacterial species which are more profound in children that clinically improve. This study aims to determine whether it is possible to maintain these bacterial changes with prolonged supplementary enteral nutrition (SEN) while returning to normal diet and if this can reduce risk of subsequent relapse for children with CD. New technologies will allow measurement of a broad range of bacteria and metabolites, to test if the clinical response to EEN and changes in gut inflammation are associated with bacterial composition and chemical products; and if maintenance of changes using SEN reduces the risk of relapse over a 12 month period. The study will aim to recruit all potential Crohn's disease children coming to a tertiary paediatric centre for colonoscopy. Once consented, an initial blood, urine and faecal sample will be requested along with 8 mucosal biopsies during the routine endoscopy session. If diagnosed with CD, and if the clinician prescribes treatment with EEN, an additional blood sample will be requested at the end of EEN, and 5 faecal and urine samples spread over 12 months; as well as some dietary information. Samples will be collected from up to 42 children with CD and 42 age- and sex-matched healthy volunteers. Initial samples taken from children who were not diagnosed with CD will be compared with CD samples to look for potential metabolic disease markers. Characterisation of faecal bacteria and metabolites in both faeces and urine; as well as measurement of blood inflammatory biomarkers will be performed.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

4 years

First QC Date

January 14, 2015

Last Update Submit

August 16, 2017

Conditions

Crohn Disease

Keywords

Enteral NutritionPediatricsMicrobiotaMetabolomics

Outcome Measures

Primary Outcomes (3)

  • Bacterial metabolism

    Change in short chain fatty acid level following treatment with enteral nutrition

    12 months

  • Gut bacterial composition

    Change in overall gut bacteria composition following treatment with enteral nutrition

    12 months

  • Mucosal bacterial composition

    Change in overall bacteria composition in mucosal tissue biopsies

    12 months

Secondary Outcomes (2)

  • Inflammatory markers

    12 months

  • Dietary information

    12 months

Study Arms (3)

A) Newly diagnosed with Crohn's disease

Children undergoing endoscopic investigations (colonoscopy) for colonic inflammation including Crohn's disease \[children who are found not to have Crohn's disease will not participate further\]. \[Intervention - clinical, not research decision - Exclusive Enteral Nutrition for 8 weeks; usually 330ml 6 times per day\] per day

Other: Exclusive Enteral Nutrition (EEN)

B) Existing diagnosis of Crohn's disease

Previously diagnosed patients with Crohn's disease due to start an 8 week standard course of treatment with EEN due to disease flare up. \[Intervention - clinical, not research decision - Exclusive Enteral Nutrition for 8 weeks; usually 330ml 6 times per day\]

Other: Exclusive Enteral Nutrition (EEN)

c) Healthy control group

Healthy children unrelated to Crohn's disease patients No intervention

Interventions

Exclusive Enteral Nutrition (EEN)OTHER

8 week standard course of treatment with EEN

A) Newly diagnosed with Crohn's diseaseB) Existing diagnosis of Crohn's disease

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with suspected or diagnosed Crohn's Disease attending a tertiary paediatric centre for treatment with exclusive enteral nutrition

You may qualify if:

  • Group A: children with suspected Crohn's Disease with scheduled colonoscopy
  • Group B: children with existing Crohn's Disease about to undergo treatment with EEN
  • Group C: healthy volunteers up to age 17 years willing to provide one urine and stool sample

You may not qualify if:

  • children who have taken antibiotics in the previous 4 weeks
  • children found not to have Crohn's Disease after colonoscopy will not be required to take any further part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

NHS Greater Glasgow & Clyde - Royal Hospital for Sick Children

Glasgow, G3 8SJ, United Kingdom

RECRUITING

NHS Ayrshire & Arran - University Hospital Crosshouse

Kilmarnock, KA2 0BE, United Kingdom

RECRUITING

NHS Forth Valley - Forth Valley Royal Hospital

Larbert, FK5 4WR, United Kingdom

NOT YET RECRUITING

NHS Greater Glasgow & Clyde - Royal Alexandra Hospital

Paisley, PA2 9PN, United Kingdom

NOT YET RECRUITING

NHS Lanarkshire - Wishaw General Hospital

Wishaw, ML2 0DP, United Kingdom

RECRUITING

Related Publications (2)

  • Logan M, MacKinder M, Clark CM, Kountouri A, Jere M, Ijaz UZ, Hansen R, McGrogan P, Russell RK, Gerasimidis K. Intestinal fatty acid binding protein is a disease biomarker in paediatric coeliac disease and Crohn's disease. BMC Gastroenterol. 2022 May 23;22(1):260. doi: 10.1186/s12876-022-02334-6.

    PMID: 35606704DERIVED

  • Gkikas K, Logan M, Nichols B, Ijaz UZ, Clark CM, Svolos V, Gervais L, Duncan H, Garrick V, Curtis L, Buchanan E, Cardigan T, Armstrong L, Delahunty C, Flynn DM, Barclay AR, Tayler R, Milling S, Hansen R, Russell RK, Gerasimidis K. Dietary triggers of gut inflammation following exclusive enteral nutrition in children with Crohn's disease: a pilot study. BMC Gastroenterol. 2021 Dec 3;21(1):454. doi: 10.1186/s12876-021-02029-4.

    PMID: 34861829DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, faecal, urine and mucosal samples retained.

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Clare M Clark, BSc MRes

CONTACT

c.clark.1@research.gla.ac.uk

Richard Russell, MBChB PhD

CONTACT

richardrussell@nhs.net

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 19, 2015

Study Start

July 18, 2014

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations

GB(5)