Crohn DiseaseiPENSNCT04225689
The Intensive Post Exclusive Enteral Nutrition Study
A study testing CD-TREAT diet in people with Crohn Disease, run by NHS Greater Glasgow and Clyde at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- CD-TREAT diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 10 Jan 2020to Feb 2024
- Phase
- Interventional
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newly diagnosed or relapsing patients with active CD, who have shown clinical improvement by the 4th week of EEN treatment
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Not yet recruiting
University Hospital Crosshouse
Crosshouse, KA2 0BE
- Not yet recruiting
Royal Hospital for Sick Children
Edinburgh, EH9 1LF
- Recruiting
Royal Hospital for Children
Glasgow, G51 4TF
- Not yet recruiting
Forth Valley Royal Hospital
Larbert, FK5 4WR
- Not yet recruiting
University Hospital Wishaw
Wishaw, ML2 0DP
About this study
Official title: The Intensive Post Exclusive Enteral Nutrition Study (iPENS): A Randomised Trial to Evaluate CD-TREAT Diet as a Food Reintroduction Regime in Children and Young Adults With Crohn's Disease
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.
Read the detailed description
A maximum of 60 participants, who have successfully responded to EEN, will be allocated to the study arms with block randomisation, with a 1:1 allocation, in random size blocks. The electronic randomisation process will be performed by an independent researcher. Those participants who do not wish to be randomised to one of the two study arms, will be offered the chance to be allocated to the group of their preference. Using this approach, inclusion of all eligible participants will be ensured, as excluding those who do not wish to be randomised, may reduce the generalisation of findings and minimise statistical power of a study with modest eligible population to recruit from.
CD-TREAT diet (intervention group)
Participants in the intervention group will consume the CD-TREAT diet exclusively without being allowed to consume additional food, for the first 3 weeks of food reintroduction, after EEN completion. They will be provided with a tailored, dietitian-devised diet, which has been designed to replicate the nutritional composition of EEN. The intervention will be overseen by qualified dietitians, including a National Health Service (NHS) research dietitian.
Unrestricted diet (control group)
Participants in the control group will consume a free, unrestricted diet for the same period, as the intervention group.
Participants in both groups will record their diet on a daily basis. The investigators will meet the participants weekly to address any potential issues they may have during the trial and to review the dietary assessment process. Standard treatment for maintenance of clinical remission will be continued, as designated by the medical team.
Participants will be asked to provide serial faecal and urine samples (n=8). Collection of a maximum of 2 blood samples, anthropometric measurements and assessment of disease activity and quality of life will be performed before and after the end of the dietary intervention. Participants will also be followed through their clinical records until they clinically relapse, or maximum up to a year after EEN completion.
The primary endpoint is the comparison of faecal calprotectin levels between the two groups at the end of the dietary intervention (3 weeks after EEN completion).
- Conditions
- Crohn Disease
- Being tested
- CD-TREAT diet
- Keywords
- food reintroduction, dietary intervention, dietary triggers, faecal calprotectin, CD-TREAT, Exclusive enteral nutrition
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD-TREAT dietOther
Dietary intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CD-TREAT diet |
| Unrestricted diet | No intervention | Free, unrestricted diet. Daily for a maximum of 21 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic inflammation
Comparison of faecal calprotectin levels between the intervention (CD-TREAT) and the control (unrestricted diet) group
Measured: Baseline to 21 days post EEN completion
Secondary outcomes (5)
Diet and faecal microbiome
Association of fermentable carbohydrates intake with relative abundance of faecal bacteria
Measured: Baseline to 21 days post EEN completion
Diet and faecal metabolome
Association of fermentable carbohydrates intake with concentration of short chain fatty acids in stool
Measured: Baseline to 21 days post EEN completion
Crohn's Disease activity score
Comparison of weighted Paediatric Crohn's Disease Activity Index score between the two groups (minimum score: 0, maximum: 125). Higher score indicates higher disease activity severity.
Measured: Baseline to 21 days post EEN completion
Blood inflammatory markers
Comparison of concentration of blood inflammatory cytokines between the two groups
Measured: Baseline to 21 days post EEN completion
Quality of life
Comparison of IMPACT III scores between the two groups (minimum score: 35, maximum: 135). Higher scores indicate better quality of life.
Measured: Baseline to 21 days post EEN completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start10 Jan 2020
- Primary completionJan 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 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
- Investigators
- Richard K Russell, MBChB, MRCP, MRCPCH, PhD, Principal investigator, NHS Greater Glasgow and ClydeKonstantinos Gerasimidis, PhD, MSc, BSc, FHEA, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225689
- Sponsor's protocol ID
- GN19GA433P
- Acronym
- iPENS
- Status last verified
- Jul 2020
- First submitted
- 20 Dec 2019
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants will be asked to provide written consent for their anonymised data to be made available to public data repositories.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intensive Post Exclusive Enteral Nutrition Study (iPENS): A Randomised Trial to Evaluate CD-TREAT Diet as a Food Reintroduction Regime in Children and Young Adults With Crohn's Disease
- ClinicalTrials.gov ID
- NCT04225689
- Acronym / sponsor ID
- iPENS / GN19GA433P
- Conditions
- Crohn Disease
- Keywords
- food reintroduction, dietary intervention, dietary triggers, faecal calprotectin, CD-TREAT, Exclusive enteral nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 13 Jan 2020 (actual)
- 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.
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.
Detailed description
A maximum of 60 participants, who have successfully responded to EEN, will be allocated to the study arms with block randomisation, with a 1:1 allocation, in random size blocks. The electronic randomisation process will be performed by an independent researcher. Those participants who do not wish to be randomised to one of the two study arms, will be offered the chance to be allocated to the group of their preference. Using this approach, inclusion of all eligible participants will be ensured, as excluding those who do not wish to be randomised, may reduce the generalisation of findings and minimise statistical power of a study with modest eligible population to recruit from.
CD-TREAT diet (intervention group)
Participants in the intervention group will consume the CD-TREAT diet exclusively without being allowed to consume additional food, for the first 3 weeks of food reintroduction, after EEN completion. They will be provided with a tailored, dietitian-devised diet, which has been designed to replicate the nutritional composition of EEN. The intervention will be overseen by qualified dietitians, including a National Health Service (NHS) research dietitian.
Unrestricted diet (control group)
Participants in the control group will consume a free, unrestricted diet for the same period, as the intervention group.
Participants in both groups will record their diet on a daily basis. The investigators will meet the participants weekly to address any potential issues they may have during the trial and to review the dietary assessment process. Standard treatment for maintenance of clinical remission will be continued, as designated by the medical team.
Participants will be asked to provide serial faecal and urine samples (n=8). Collection of a maximum of 2 blood samples, anthropometric measurements and assessment of disease activity and quality of life will be performed before and after the end of the dietary intervention. Participants will also be followed through their clinical records until they clinically relapse, or maximum up to a year after EEN completion.
The primary endpoint is the comparison of faecal calprotectin levels between the two groups at the end of the dietary intervention (3 weeks after EEN completion).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD-TREAT diet | Experimental | Other: CD-TREAT dietSolid 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. |
| Unrestricted diet | No intervention | –Free, unrestricted diet. Daily for a maximum of 21 days. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newly diagnosed or relapsing patients with active CD, who have shown clinical improvement by the 4th week of EEN treatment
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| CD-TREAT dietDietary intervention | Other | CD-TREAT diet |
Primary outcome
Colonic inflammation
Time frame: Baseline to 21 days post EEN completion
Comparison of faecal calprotectin levels between the intervention (CD-TREAT) and the control (unrestricted diet) group
5 secondary outcomes
Diet and faecal microbiome
Time frame: Baseline to 21 days post EEN completion
Diet and faecal metabolome
Time frame: Baseline to 21 days post EEN completion
Crohn's Disease activity score
Time frame: Baseline to 21 days post EEN completion
Blood inflammatory markers
Time frame: Baseline to 21 days post EEN completion
Quality of life
Time frame: Baseline to 21 days post EEN completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: Yes. Participants will be asked to provide written consent for their anonymised data to be made available to public data repositories.
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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.
Richard K Russell, MBChB, MRCP, MRCPCH, PhD principal investigator
NHS Greater Glasgow and Clyde
Konstantinos Gerasimidis, PhD, MSc, BSc, FHEA principal investigator
University of Glasgow
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD-TREAT diet in people with 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 1 inclusion and 4 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 Jul 2020. 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 Konstantinos Gkikas, MSc, Bsc (07759451611, k.gkikas.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?
Colonic inflammation (time frame: Baseline to 21 days post EEN completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2020.