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Bacteria & Inflammation in the Gut (BIG) Study (BIG)

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ClinicalTrials.gov Identifier: NCT02341248
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

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.


Condition or disease Intervention/treatment
Crohn Disease Other: Exclusive Enteral Nutrition (EEN)

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Gut Microbial Taxonomy and Metabolism in Paediatric Crohn's Disease During Exclusive and Supplementary Enteral Nutrition Using -Omics Technologies
Actual Study Start Date : July 18, 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort Intervention/treatment
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)
8 week standard course of treatment with 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)
8 week standard course of treatment with EEN

c) Healthy control group
Healthy children unrelated to Crohn's disease patients No intervention



Primary Outcome Measures :
  1. Bacterial metabolism [ Time Frame: 12 months ]
    Change in short chain fatty acid level following treatment with enteral nutrition

  2. Gut bacterial composition [ Time Frame: 12 months ]
    Change in overall gut bacteria composition following treatment with enteral nutrition

  3. Mucosal bacterial composition [ Time Frame: 12 months ]
    Change in overall bacteria composition in mucosal tissue biopsies


Secondary Outcome Measures :
  1. Inflammatory markers [ Time Frame: 12 months ]
    Change in faecal calprotectin level before and after treatment with EEN

  2. Dietary information [ Time Frame: 12 months ]
    Comparison of dietary composition between groups


Biospecimen Retention:   Samples Without DNA
Blood, faecal, urine and mucosal samples retained.


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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children with suspected or diagnosed Crohn's Disease attending a tertiary paediatric centre for treatment with exclusive enteral nutrition
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341248


Contacts
Contact: Clare M Clark, BSc MRes c.clark.1@research.gla.ac.uk
Contact: Richard Russell, MBChB PhD richardrussell@nhs.net

Locations
United Kingdom
NHS Greater Glasgow & Clyde - Royal Hospital for Sick Children Recruiting
Glasgow, United Kingdom, G3 8SJ
Contact: Clare M Clark, BSc MRes       c.clark.1@research.gla.ac.uk   
Contact: Richard Russell, MBChB PhD       richardrussell@nhs.net   
NHS Ayrshire & Arran - University Hospital Crosshouse Recruiting
Kilmarnock, United Kingdom, KA2 0BE
Contact: Lawrence Armstrong         
NHS Forth Valley - Forth Valley Royal Hospital Not yet recruiting
Larbert, United Kingdom, FK5 4WR
Contact: Ghassan Al-Hourani         
NHS Greater Glasgow & Clyde - Royal Alexandra Hospital Not yet recruiting
Paisley, United Kingdom, PA2 9PN
Contact: Mohammed Iqbal         
NHS Lanarkshire - Wishaw General Hospital Recruiting
Wishaw, United Kingdom, ML2 0DP
Contact: Caroline Delahunty         
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow

Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02341248     History of Changes
Other Study ID Numbers: GN14KH275
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by NHS Greater Glasgow and Clyde:
Enteral Nutrition
Pediatrics
Microbiota
Metabolomics

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases