Clinical Trial

Biologics and Partial Enteral Nutrition Study

Study acronym: BIOPIC
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-04-23; most recent amendment 2021-11-29.
Status change: Not Yet Recruiting → Recruiting 2021-09-24
Trial Details
NCT Number NCT04859088
Lead Sponsor NHS Greater Glasgow and Clyde
Collaborators: University of Glasgow
Conditions Crohn Disease
Enrollment 80 participants
Start Date 2021-09-20
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2021-11-30