The Intensive Post Exclusive Enteral Nutrition Study (iPENS)
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|ClinicalTrials.gov Identifier: NCT04225689|
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : July 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Other: CD-TREAT diet||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Electronic random block-size randomisation will be performed by a researcher not involved in study recruitment. Allocation to study arm will be revealed to participants after provision of informed consent.|
|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|
|Actual Study Start Date :||January 10, 2020|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||February 2024|
Experimental: CD-TREAT diet
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.
Other: CD-TREAT diet
No Intervention: Unrestricted diet
Free, unrestricted diet. Daily for a maximum of 21 days.
- 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
- Diet and faecal microbiome [ Time Frame: Baseline to 21 days post EEN completion ]Association of fermentable carbohydrates intake with relative abundance of faecal bacteria
- Diet and faecal metabolome [ Time Frame: Baseline to 21 days post EEN completion ]Association of fermentable carbohydrates intake with concentration of short chain fatty acids in stool
- Crohn's Disease activity score [ Time Frame: Baseline to 21 days post EEN completion ]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.
- Blood inflammatory markers [ Time Frame: Baseline to 21 days post EEN completion ]Comparison of concentration of blood inflammatory cytokines between the two groups
- Quality of life [ Time Frame: Baseline to 21 days post EEN completion ]Comparison of IMPACT III scores between the two groups (minimum score: 35, maximum: 135). Higher scores indicate better quality of life.
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): NCT04225689
|Contact: Konstantinos Gkikas, MSc, Bscfirstname.lastname@example.org|
|Contact: Richard K Russell, MBChB, MRCP, MRCPCH, PhDemail@example.com|
|University Hospital Crosshouse||Not yet recruiting|
|Crosshouse, United Kingdom, KA2 0BE|
|Royal Hospital for Sick Children||Not yet recruiting|
|Edinburgh, United Kingdom, EH9 1LF|
|Royal Hospital for Children||Recruiting|
|Glasgow, United Kingdom, G51 4TF|
|Forth Valley Royal Hospital||Not yet recruiting|
|Larbert, United Kingdom, FK5 4WR|
|University Hospital Wishaw||Not yet recruiting|
|Wishaw, United Kingdom, ML2 0DP|
|Principal Investigator:||Richard K Russell, MBChB, MRCP, MRCPCH, PhD||NHS Greater Glasgow and Clyde|
|Principal Investigator:||Konstantinos Gerasimidis, PhD, MSc, BSc, FHEA||University of Glasgow|