Biologics and Partial Enteral Nutrition Study

• Register: ClinicalTrials.gov
• Last refreshed on: 13 December 2021
• Main ID: NCT04859088
• Date of registration: 15/04/2021
• Prospective Registration: Yes
• Primary sponsor: NHS Greater Glasgow and Clyde
• Public title: Biologics and Partial Enteral Nutrition Study BIOPIC
• Scientific title: Combining Partial Enteral Nutrition With Biologics to Optimise Induction and Maintenance Therapy for Adults With Active Ileocolonic Crohn's Disease
• Date of first enrolment: September 20, 2021
• Target sample size: 80
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04859088
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United Kingdom

Contacts

• Name: Aleksandra Jatkowska, BSc (Hons)

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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
(TNFa antagonist) induction treatment (160 mg day 0, 80 mg at 2 weeks and then 40 mg
every 2 weeks).

Exclusion Criteria:

- 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-TNFa 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)



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Dietary Supplement: Partial Enteral Nutrition

Primary Outcome(s)

Crohn's Disease Activity Index [Time Frame: Baseline to 52 weeks]

Secondary Outcome(s)

Body fat mass [Time Frame: Baseline to 12 weeks]

Blood C-Reactive Protein [Time Frame: Baseline to 12 weeks]

Body fat-free mass [Time Frame: Baseline to 12 weeks]

Faecal Calprotectin [Time Frame: Baseline to 12 weeks]

Blood adalimumab [Time Frame: Baseline to 12 weeks]

Blood Haemoglobin [Time Frame: Baseline to 12 weeks]

Dosage of biologics [Time Frame: Baseline to 52 weeks]

Blood Erythrocyte Sedimentation Rate [Time Frame: Baseline to 12 weeks]

Body Mass Index [Time Frame: Baseline to 12 weeks]

Body weight [Time Frame: Baseline to 12 weeks]

Harvey-Bradshaw Index [Time Frame: Baseline to 52 weeks]

Self-Administered Inflammatory Bowel Disease Questionnaire [Time Frame: Baseline to 12 weeks]

Steroid-free remission [Time Frame: Baseline to 52 weeks]

Blood anti-drug antibodies [Time Frame: Baseline to 12 weeks]

Micronutrient status [Time Frame: Baseline to 12 weeks]

Blood Albumin [Time Frame: Baseline to 12 weeks]

Blood immunophenotype [Time Frame: Baseline to 12 weeks]

Handgrip strength [Time Frame: Baseline to 12 weeks]

Secondary ID(s)

GN21RH169

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Glasgow