The intensive Post Exclusive Enteral Nutrition Study (iPENS)
Research type
Research Study
Full 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.
IRAS ID
259943
Contact name
Richard Kay Russell
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Crohn’s disease (CD) is a chronic inflammatory condition with phases where the disease is active and other, where there are no disease symptoms. Exclusive enteral nutrition, 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. It is important to study why this is happening and to explore if diet and gut germs (bacteria) play a role. We also aim to test whether following 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 liquid diet completion. Initial results from our ongoing trial show that CD-TREAT is effective in reducing gut inflammation and improving disease symptoms in 80% of children with active CD.
Children and young adults with CD (6-17 years) who have successfully responded to the liquid diet will be allocated by chance to follow either the CD-TREAT diet OR a free, unrestricted diet for 3 weeks. Participants who do not want to be randomised can choose the group of their preference. A maximum of 8 stool (poo) and urine samples, 2 blood samples and detailed dietary information will be collected during the study period. All foods and meals for both groups will be purchased and delivered to the participants’ home free of charge. The main outcome of the study is the difference in gut inflammation levels between the two groups after 3 weeks. Healthy volunteers will also be recruited to serve as a comparison group for the CD patients.REC name
West of Scotland REC 5
REC reference
19/WS/0163
Date of REC Opinion
22 Nov 2019
REC opinion
Further Information Favourable Opinion