The Intensive Post Exclusive Enteral Nutrition Study

Crohn Disease Clinical Trial

— iPENS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04225689
• Other study ID #: GN19GA433P
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: February 2024

Study information

• Verified date: July 2020
• Source: NHS Greater Glasgow and Clyde
• Contact: Konstantinos Gkikas, MSc, Bsc
• Phone: 07759451611
• Email: k.gkikas.1[@]research.gla.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: February 2024
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• CD-TREAT diet
Dietary intervention

Locations

Country	Name	City	State
United Kingdom	University Hospital Crosshouse	Crosshouse
United Kingdom	Royal Hospital for Sick Children	Edinburgh
United Kingdom	Royal Hospital for Children	Glasgow
United Kingdom	Forth Valley Royal Hospital	Larbert
United Kingdom	University Hospital Wishaw	Wishaw

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonic inflammation	Comparison of faecal calprotectin levels between the intervention (CD-TREAT) and the control (unrestricted diet) group	Baseline to 21 days post EEN completion
Secondary	Diet and faecal microbiome	Association of fermentable carbohydrates intake with relative abundance of faecal bacteria	Baseline to 21 days post EEN completion
Secondary	Diet and faecal metabolome	Association of fermentable carbohydrates intake with concentration of short chain fatty acids in stool	Baseline to 21 days post EEN completion
Secondary	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.	Baseline to 21 days post EEN completion
Secondary	Blood inflammatory markers	Comparison of concentration of blood inflammatory cytokines between the two groups	Baseline to 21 days post EEN completion
Secondary	Quality of life	Comparison of IMPACT III scores between the two groups (minimum score: 35, maximum: 135). Higher scores indicate better quality of life.	Baseline to 21 days post EEN completion