Combining Partial Enteral Nutrition With Biologics to Optimise Induction and Maintenance Therapy for Adults With Active Ileocolonic Crohn's Disease

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Crohn's disease (CD) is a chronic, incurable condition associated with inflammation in the gut lining. It causes diarrhoea, severe abdominal pain, poor nutrition and adversely affects the quality of life of sufferers. Two of the best treatments currently used in people with CD are drug injections and/or infusions (biologics), and a liquid-only diet using specialised milkshakes. However, treatment with biologics is only successful in approximately 40% of the patients, and although treatment with the liquid-only diet has a better safety and effectiveness profile, it is difficult for patients to stick to this as their sole source of nutrition for 6-8 weeks, particularly for adults. BIOPIC study aims to investigate whether replacing half of a habitual diet with specialised milkshakes will improve response to standard treatment with biologics in adults with CD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:

• Eligible participants are all adults (≥16 years old) with active CD (defined as Crohn's Disease Activity Index ≥ 150) who are due to initiate standard adalimumab (TNFα antagonist) induction treatment (160 mg day 0, 80 mg at 2 weeks and then 40 mg every 2 weeks).

Locations
Other Locations
United Kingdom
Gartnavel General Hospital
RECRUITING
Glasgow
Glasgow Royal Infirmary
RECRUITING
Glasgow
Queen Elizabeth University Hospital
RECRUITING
Glasgow
The New Victoria Hospital
RECRUITING
Glasgow
Contact Information
Primary
Aleksandra Jatkowska, BSc (Hons)
a.jatkowska.1@research.gla.ac.uk
07743585420
Backup
Bernadette E White, MBio (Hons)
b.white.1@research.gla.ac.uk
07719607863
Time Frame
Start Date: 2021-09-20
Estimated Completion Date: 2026-09
Participants
Target number of participants: 80
Treatments
Experimental: Partial Enteral Nutrition
Patients allocated to Partial Enteral Nutrition study arm will be asked to replace 50% of their daily energy requirements with a proprietary formula (Modulen IBD, Nestle) for 6 weeks alongside standard care of treatment with adalimumab as induction therapy.
No_intervention: Unrestricted diet
Patients allocated to unrestricted diet study arm will be asked to follow their normal diet for 6 weeks alongside standard care of treatment with adalimumab as induction therapy.
Related Therapeutic Areas
Sponsors
Collaborators: University of Glasgow
Leads: NHS Greater Glasgow and Clyde

This content was sourced from clinicaltrials.gov

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