Biologics and Partial Enteral Nutrition Study

Official title

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

Overview

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.

Detailed description

80 adult patients with active CD who are due to start biologic injections therapy with adalimumab as part of their standard of care for the first time will be recruited for this study. Patients will be randomly allocated to replace either half of their normal diet with nutritionally complete milkshakes or to follow their usual diet for 6 weeks. The investigators will compare the proportion of patients whose symptoms and disease markers will improve between the two groups at 6 and 12 weeks, and how many of them will remain symptoms-free for up to a year following treatment. The investigators will also explore whether the half-liquid diet will influence patients' nutrition and quality of life. Last, the investigators will investigate if gut bacteria changes and their metabolites associate with patients' eating habits and their responses to treatment with biologics.

The primary aim of the BIOPIC study is to investigate if replacement of 50% of habitual food intake with a proprietary liquid diet for 6 weeks will improve remission rates at 12 weeks in adult patients with active ileocolonic CD treated with first-line biologics (TNFα antagonists, adalimumab) as their standard treatment of care. The secondary aim is to investigate if replacement of 50% of habitual food intake with a proprietary liquid diet for 6 weeks will prolong remission in adult patients with active ileocolonic CD treated with first-line biologics (TNFα antagonists) as their standard treatment of care.

Interventions

• Dietary supplement Partial Enteral Nutrition
  Dietary intervention (Liquid food replacement intervention)

Primary outcome measures

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

Secondary outcome measures (12)

• Harvey-Bradshaw Index [Time frame: Baseline to 52 weeks]
• Faecal Calprotectin [Time frame: Baseline to 12 weeks]
• Blood C-Reactive Protein [Time frame: Baseline to 12 weeks]
• Blood Erythrocyte Sedimentation Rate [Time frame: Baseline to 12 weeks]
• Blood Albumin [Time frame: Baseline to 12 weeks]
• Blood Haemoglobin [Time frame: Baseline to 12 weeks]
• Steroid-free remission [Time frame: Baseline to 52 weeks]
• Dosage of biologics [Time frame: Baseline to 52 weeks]
• Blood anti-drug antibodies [Time frame: Baseline to 12 weeks]
• Blood adalimumab [Time frame: Baseline to 12 weeks]
• Micronutrient status [Time frame: Baseline to 12 weeks]
• Blood immunophenotype [Time frame: Baseline to 12 weeks]

Eligibility 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 (TNFα 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-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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 4 centers

• Glasgow Royal Infirmary — Glasgow
• Queen Elizabeth University Hospital — Glasgow
• Gartnavel General Hospital — Glasgow
• The New Victoria Hospital — Glasgow

Identifiers

NCT: NCT04859088 · GN21RH169

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗