Biologics and Partial Enteral Nutrition Study
Recruiting · NCT04859088 · Interventional (participants receive a specific treatment) · Lead sponsor: NHS Greater Glasgow and Clyde
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
Where it is running
4 locations listed.
- Gartnavel General Hospital - Glasgow, United Kingdom
- The New Victoria Hospital - Glasgow, United Kingdom
- Glasgow Royal Infirmary - Glasgow, Scotland, United Kingdom
- Queen Elizabeth University Hospital - Glasgow, Scotland, United Kingdom