At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Partial Enteral Nutrition (supplement)
- How long the study runs
- Study runs about 60 months (dates as stated)
- About the drug or intervention
- Partial Enteral Nutrition — supplement: Dietary intervention (Liquid food replacement intervention)
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 80
- Started
- 2021-09-20
- Last checked
- 2021-11
Plain English Summary
What is this study?
- • Testing a new treatment for crohn disease
- • NA - 80 participants
- • Crohn's disease (CD) is a chronic, incurable condition associated with inflammation in the gut lining
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with crohn disease
Where?
- • Glasgow - Glasgow Royal Infirmary
- • Glasgow - Queen Elizabeth University Hospital
- • Glasgow - Gartnavel General Hospital
- • Glasgow - The New Victoria Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
Biomarkers mentioned
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (4 UK sites)
Glasgow Royal Infirmary
Glasgow G31 2ER, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Gartnavel General Hospital
Glasgow G12 0YN, United Kingdom
The New Victoria Hospital
Glasgow G42 9LF, United Kingdom
How to Get in Touch
Aleksandra Jatkowska, BSc (Hons)
Sponsor contactCONTACT
Bernadette E White, MBio (Hons)
Sponsor contactCONTACT
