Clinical trial NCT04225689: The Intensive Post Exclusive Enteral Nutrition 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Keywords: food reintroduction
dietary intervention
dietary triggers
faecal calprotectin
CD-TREAT
Exclusive enteral nutrition
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2020-01-13
Enrollment: 58
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

Newly diagnosed or relapsing patients with active CD, who have shown clinical improvement by the 4th week of EEN treatment

Exclusion Criteria:

1. Administration of another induction treatment (e.g. corticosteroids, biologic agents).
2. Lack of clinical improvement with EEN treatment, as assessed by the clinical team.
3. Enrolment in other studies investigating the efficacy of novel therapies for maintenance or induction of remission.
4. Patients or families unable to provide written consent for participation in the study.

Primary outcomes:
measure: Colonic inflammation
timeFrame: Baseline to 21 days post EEN completion
Secondary outcomes:
measure: Diet and faecal microbiome
timeFrame: Baseline to 21 days post EEN completion
measure: Diet and faecal metabolome
timeFrame: Baseline to 21 days post EEN completion
measure: Crohn's Disease activity score
timeFrame: Baseline to 21 days post EEN completion
measure: Blood inflammatory markers
timeFrame: Baseline to 21 days post EEN completion
measure: Quality of life
timeFrame: Baseline to 21 days post EEN completion
Other outcomes:
Locations:
city: Crosshouse
country: United Kingdom
facility: University Hospital Crosshouse
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Children
city: Larbert
country: United Kingdom
facility: Forth Valley Royal Hospital
city: Wishaw
country: United Kingdom
facility: University Hospital Wishaw
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Richard K Russell, MBChB, MRCP, MRCPCH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Konstantinos Gerasimidis, PhD, MSc, BSc, FHEA
role: PRINCIPAL_INVESTIGATOR
References: