Crohn DiseaseBIGNCT02341248
Bacteria & Inflammation in the Gut (BIG) Study
An observational study of Crohn Disease, run by NHS Greater Glasgow and Clyde at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Exclusive Enteral Nutrition (EEN)
- How many people
- 200 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 18 Jul 2014to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with suspected or diagnosed Crohn's Disease attending a tertiary paediatric centre for treatment with exclusive enteral nutrition
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
Clare M Clark, BSc MRes contact
Richard Russell, MBChB PhD contact
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Recruiting
NHS Greater Glasgow & Clyde - Royal Hospital for Sick Children
Glasgow, G3 8SJ
Clare M Clark, BSc MRes, c.clark.1@research.gla.ac.uk
Richard Russell, MBChB PhD, richardrussell@nhs.net
- Recruiting
NHS Ayrshire & Arran - University Hospital Crosshouse
Kilmarnock, KA2 0BE
Lawrence Armstrong
- Not yet recruiting
NHS Forth Valley - Forth Valley Royal Hospital
Larbert, FK5 4WR
Ghassan Al-Hourani
- Not yet recruiting
NHS Greater Glasgow & Clyde - Royal Alexandra Hospital
Paisley, PA2 9PN
Mohammed Iqbal
- Recruiting
NHS Lanarkshire - Wishaw General Hospital
Wishaw, ML2 0DP
Caroline Delahunty
About this study
Official title: Gut Microbial Taxonomy and Metabolism in Paediatric Crohn's Disease During Exclusive and Supplementary Enteral Nutrition Using -Omics Technologies
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.
Read more
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.
Read the detailed description
The null hypothesis is that the clinical response to exclusive enteral nutrition (EEN) and reduction of colonic inflammatory markers are not associated with a characteristic bacterial taxonomy (composition) and metabolites (functionality); and that maintenance of any bacterial changes with supplementary enteral nutrition (SEN), while returning to habitual diet, does not reduce the risk of disease relapse.
The study design will build on previous work by looking at differences in both the gut bacteria (faecal and mucosal) and bacterial metabolic activity at different stages of disease activity. Changes in bacterial composition between disease groups will be examined; between Crohn's disease children on different treatments; and between different sites in the gut. Crohn's disease biomarkers in faeces and urine will also be assessed by analysing bacterial metabolites.
Up to a total of 42 children with Crohn's Disease will be recruited. 42 healthy children will also be recruited to provide a faecal and urine sample, to show the normal variety of gut bacteria and metabolites in healthy children for comparison.
Children who underwent colonoscopy but did not have Crohn's disease will be used as a comparison group to try and identify Crohn's disease bacterial signatures from faeces and urine, and as a non-Crohn's disease control group for comparison of mucosal biopsies.
Recruitment Three groups of children will participate in this study. A. 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 in the follow up aspect (during treatment with EEN) of this study].
- Previously diagnosed patients with Crohn's disease due to start an 8 week standard course of treatment with EEN due to disease flare up.
- Healthy children unrelated to Crohn's disease patients will be used as a control group.
Groups A and B: an initial blood, urine, faecal sample followed by 5 further faecal and urine samples over 12 months; and dietary information.
[Group A will also have 8 mucosal biopsies taken during routine endoscopy]. During treatment with EEN (clinical decision), an additional blood sample will be requested during routine blood sampling at start and end of treatment.
Group C: 1 urine and faecal sample will be requested.
All groups will have height, weight and grip strength measured at baseline. Participant receiving EEN will have this repeated 60 days after start of treatment and 60 days after end of treatment.
Detailed Methods Preliminary health check by means of a short health questionnaire - basic health information, age, any medication.
Mucosal samples: in newly diagnosed patients having a colonoscopy for diagnostic purposes, an additional 6 mucosal biopsy samples; 2 from the terminal ileum when possible, 2 from the proximal colon and 2 from the distal colon will be taken (14-16 are collected at normal colonoscopy). An additional 2 biopsy samples will also be collected from the duodenum during upper endoscopy.
Dietary information: habitual dietary intake and eating patterns assessed using validated Food Frequency Questionnaire (FFQ); a 5 step multiple pass 24 hour dietary recall questionnaire for data on actual diet at time of faecal and urine sampling.
EEN compliance (groups A\&B only): completion of short EEN compliance questionnaire at 28 day and 56 day time points.
Medication and Disease History: information on disease activity, medication and medical history collected from medical notes.
Lab Assays Bacterial diversity: The gut bacterial diversity and composition from stool samples will be measured using molecular techniques such as quantitative polymerase chain reaction (PCR) from bacterial ribosomal DNA and next generation sequencing (metagenomics). These techniques will also be used to look at the composition of bacteria associated with mucosal tissue biopsies. Changes in overall gut bacteria composition using standard numerical indices will be measured across the 6 faecal samples collected over the 12 month period, as well as between groups.
Bacterial metabolism: A large number of different products from bacterial metabolism, such as short chain fatty acids, sulphide, and ammonia will be measured using a range of techniques including gas chromatography and gas chromatography mass spectrometry (GCMS) (metabolomics). Faecal pH, a marker of bacterial fermentation, will also be measured.
Disease markers: Other disease markers and metabolites such as faecal calprotectin, will be measured from faecal samples .
- Conditions
- Crohn Disease
- Being tested
- Exclusive Enteral Nutrition (EEN)
- Keywords
- Enteral Nutrition, Pediatrics, Microbiota, Metabolomics
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusive Enteral Nutrition (EEN)Other
8 week standard course of treatment with EEN
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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] Receives: Other: Exclusive Enteral Nutrition (EEN) | |
| c) Healthy control group | Healthy children unrelated to Crohn's disease patients No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial metabolism
Change in short chain fatty acid level following treatment with enteral nutrition
Measured: 12 months
Gut bacterial composition
Change in overall gut bacteria composition following treatment with enteral nutrition
Measured: 12 months
Mucosal bacterial composition
Change in overall bacteria composition in mucosal tissue biopsies
Measured: 12 months
Secondary outcomes (2)
Inflammatory markers
Change in faecal calprotectin level before and after treatment with EEN
Measured: 12 months
Dietary information
Comparison of dietary composition between groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study start18 Jul 2014
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341248
- Sponsor's protocol ID
- GN14KH275
- Acronym
- BIG
- Status last verified
- Aug 2017
- First submitted
- 14 Jan 2015
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
White B, Curle J, Gervais L, Wands D, Nichols B, Hansen R, Russell RK, Gerasimidis K, Milling S. Exclusive enteral nutrition impacts peripheral blood mononuclear cell profile of children with Crohn's disease. J Pediatr Gastroenterol Nutr. 2024 Jul;79(1):148-153. doi: 10.1002/jpn3.12258. Epub 2024 May 23.
PubMed 38779951Logan 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.
PubMed 35606704Gkikas 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.
PubMed 34861829
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbial Taxonomy and Metabolism in Paediatric Crohn's Disease During Exclusive and Supplementary Enteral Nutrition Using -Omics Technologies
- ClinicalTrials.gov ID
- NCT02341248
- Acronym / sponsor ID
- BIG / GN14KH275
- Conditions
- Crohn Disease
- Keywords
- Enteral Nutrition, Pediatrics, Microbiota, Metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 18 Jul 2014 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The null hypothesis is that the clinical response to exclusive enteral nutrition (EEN) and reduction of colonic inflammatory markers are not associated with a characteristic bacterial taxonomy (composition) and metabolites (functionality); and that maintenance of any bacterial changes with supplementary enteral nutrition (SEN), while returning to habitual diet, does not reduce the risk of disease relapse.
The study design will build on previous work by looking at differences in both the gut bacteria (faecal and mucosal) and bacterial metabolic activity at different stages of disease activity. Changes in bacterial composition between disease groups will be examined; between Crohn's disease children on different treatments; and between different sites in the gut. Crohn's disease biomarkers in faeces and urine will also be assessed by analysing bacterial metabolites.
Up to a total of 42 children with Crohn's Disease will be recruited. 42 healthy children will also be recruited to provide a faecal and urine sample, to show the normal variety of gut bacteria and metabolites in healthy children for comparison.
Children who underwent colonoscopy but did not have Crohn's disease will be used as a comparison group to try and identify Crohn's disease bacterial signatures from faeces and urine, and as a non-Crohn's disease control group for comparison of mucosal biopsies.
Recruitment Three groups of children will participate in this study. A. 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 in the follow up aspect (during treatment with EEN) of this study].
- Previously diagnosed patients with Crohn's disease due to start an 8 week standard course of treatment with EEN due to disease flare up.
- Healthy children unrelated to Crohn's disease patients will be used as a control group.
Groups A and B: an initial blood, urine, faecal sample followed by 5 further faecal and urine samples over 12 months; and dietary information.
[Group A will also have 8 mucosal biopsies taken during routine endoscopy]. During treatment with EEN (clinical decision), an additional blood sample will be requested during routine blood sampling at start and end of treatment.
Group C: 1 urine and faecal sample will be requested.
All groups will have height, weight and grip strength measured at baseline. Participant receiving EEN will have this repeated 60 days after start of treatment and 60 days after end of treatment.
Detailed Methods Preliminary health check by means of a short health questionnaire - basic health information, age, any medication.
Mucosal samples: in newly diagnosed patients having a colonoscopy for diagnostic purposes, an additional 6 mucosal biopsy samples; 2 from the terminal ileum when possible, 2 from the proximal colon and 2 from the distal colon will be taken (14-16 are collected at normal colonoscopy). An additional 2 biopsy samples will also be collected from the duodenum during upper endoscopy.
Dietary information: habitual dietary intake and eating patterns assessed using validated Food Frequency Questionnaire (FFQ); a 5 step multiple pass 24 hour dietary recall questionnaire for data on actual diet at time of faecal and urine sampling.
EEN compliance (groups A\&B only): completion of short EEN compliance questionnaire at 28 day and 56 day time points.
Medication and Disease History: information on disease activity, medication and medical history collected from medical notes.
Lab Assays Bacterial diversity: The gut bacterial diversity and composition from stool samples will be measured using molecular techniques such as quantitative polymerase chain reaction (PCR) from bacterial ribosomal DNA and next generation sequencing (metagenomics). These techniques will also be used to look at the composition of bacteria associated with mucosal tissue biopsies. Changes in overall gut bacteria composition using standard numerical indices will be measured across the 6 faecal samples collected over the 12 month period, as well as between groups.
Bacterial metabolism: A large number of different products from bacterial metabolism, such as short chain fatty acids, sulphide, and ammonia will be measured using a range of techniques including gas chromatography and gas chromatography mass spectrometry (GCMS) (metabolomics). Faecal pH, a marker of bacterial fermentation, will also be measured.
Disease markers: Other disease markers and metabolites such as faecal calprotectin, will be measured from faecal samples .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A) Newly diagnosed with Crohn's disease | – | Other: Exclusive Enteral Nutrition (EEN)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 |
| B) Existing diagnosis of Crohn's disease | – | Other: Exclusive Enteral Nutrition (EEN)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] |
| c) Healthy control group | – | –Healthy children unrelated to Crohn's disease patients No intervention |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with suspected or diagnosed Crohn's Disease attending a tertiary paediatric centre for treatment with exclusive enteral nutrition
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exclusive Enteral Nutrition (EEN)8 week standard course of treatment with EEN | Other | A) Newly diagnosed with Crohn's disease, B) Existing diagnosis of Crohn's disease |
Primary outcome
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
2 secondary outcomes
Inflammatory markers
Time frame: 12 months
Dietary information
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Derived from this study: PubMed 38779951White B, Curle J, Gervais L, Wands D, Nichols B, Hansen R, Russell RK, Gerasimidis K, Milling S. Exclusive enteral nutrition impacts peripheral blood mononuclear cell profile of children with Crohn's disease. J Pediatr Gastroenterol Nutr. 2024 Jul;79(1):148-153. doi: 10.1002/jpn3.12258. Epub 2024 May 23.
- Derived from this study: PubMed 35606704Logan 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.
- Derived from this study: PubMed 34861829Gkikas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare M Clark, BSc MRes contact
Richard Russell, MBChB PhD contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by NHS Greater Glasgow and Clyde at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clare M Clark, BSc MRes (c.clark.1@research.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial metabolism (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341248, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.