RecruitingNot ApplicableNCT04859088

Biologics and Partial Enteral Nutrition Study

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

Sponsor

NHS Greater Glasgow and Clyde

Enrollment

80 participants

Start Date

Sep 20, 2021

Study Type

INTERVENTIONAL

Conditions

Crohn Disease

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

Min Age: 16 Years

Inclusion Criteria1

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).

Exclusion Criteria14

Inability to provide written consent to participate in the study
Pregnant and/or breastfeeding individuals
Presence of stoma
Presence of short bowel syndrome
Previous treatment with an anti-TNFα inhibitor
Use of any other biologic therapy or oral small molecule therapy within the last 12 weeks
Patients currently receiving oral or intravenous steroids at a dosage \>20mg/day prednisolone or \>9mg budesonide
Introduction of or change in dose of immunomodulator (azathioprine, mercaptopurine, methotrexate) within the past 8 weeks
Use of oral antibiotics within the past 4 weeks
CD with a major fistulising or symptomatic fibrotic stricturing phenotype
Patients tested positive for blood-borne viruses such as HIV and Hepatitis
Patients with untreated tuberculosis (latent or active)
Current enrolment in other studies of an investigational product or dietary intervention
Food allergies, which do not permit participation in the study (e.g., cow's milk allergy)