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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
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

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.

Condition or disease Intervention/treatment Phase
Crohn Disease Other: CD-TREAT diet Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
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.
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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
Dietary intervention

No Intervention: Unrestricted diet
Free, unrestricted diet. Daily for a maximum of 21 days.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Diet and faecal microbiome [ Time Frame: Baseline to 21 days post EEN completion ]
    Association of fermentable carbohydrates intake with relative abundance of faecal bacteria

  2. 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

  3. 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.

  4. Blood inflammatory markers [ Time Frame: Baseline to 21 days post EEN completion ]
    Comparison of concentration of blood inflammatory cytokines between the two groups

  5. 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.



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Konstantinos Gkikas, MSc, Bsc 07759451611 k.gkikas.1@research.gla.ac.uk
Contact: Richard K Russell, MBChB, MRCP, MRCPCH, PhD 01414516543 richardrussell@nhs.net

Locations
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United Kingdom
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
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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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
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT04225689    
Other Study ID Numbers: GN19GA433P
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants will be asked to provide written consent for their anonymised data to be made available to public data repositories.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NHS Greater Glasgow and Clyde:
food reintroduction
dietary intervention
dietary triggers
faecal calprotectin
CD-TREAT
Exclusive enteral nutrition
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases