Bacteria & Inflammation in the Gut (BIG) Study (BIG)
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ClinicalTrials.gov Identifier: NCT02341248 |
Recruitment Status : Unknown
Verified August 2017 by NHS Greater Glasgow and Clyde.
Recruitment status was: Recruiting
First Posted : January 19, 2015
Last Update Posted : August 21, 2017
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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 |
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Crohn Disease | Other: Exclusive Enteral Nutrition (EEN) |

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 |

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
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- Bacterial metabolism [ Time Frame: 12 months ]Change in short chain fatty acid level following treatment with enteral nutrition
- Gut bacterial composition [ Time Frame: 12 months ]Change in overall gut bacteria composition following treatment with enteral nutrition
- Mucosal bacterial composition [ Time Frame: 12 months ]Change in overall bacteria composition in mucosal tissue biopsies
- Inflammatory markers [ Time Frame: 12 months ]Change in faecal calprotectin level before and after treatment with EEN
- Dietary information [ Time Frame: 12 months ]Comparison of dietary composition between groups
Biospecimen Retention: Samples Without DNA

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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 |
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

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
Contact: Clare M Clark, BSc MRes | c.clark.1@research.gla.ac.uk | ||
Contact: Richard Russell, MBChB PhD | richardrussell@nhs.net |
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 |
Responsible Party: | NHS Greater Glasgow and Clyde |
ClinicalTrials.gov Identifier: | NCT02341248 |
Other Study ID Numbers: |
GN14KH275 |
First Posted: | January 19, 2015 Key Record Dates |
Last Update Posted: | August 21, 2017 |
Last Verified: | August 2017 |
Enteral Nutrition Pediatrics Microbiota Metabolomics |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |