Actively Recruiting
Biologics and Partial Enteral Nutrition Study
Led by NHS Greater Glasgow and Clyde · Updated on 2021-11-30
80
Participants Needed
4
Research Sites
258 weeks
Total Duration
On this page
Sponsors
N
NHS Greater Glasgow and Clyde
Lead Sponsor
U
University of Glasgow
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Biologics and Partial Enteral Nutrition Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 16 years or older with active Crohn's disease (Crohn's Disease Activity Index 150 or higher)
- Planned to start standard adalimumab treatment (160 mg on day 0, 80 mg at 2 weeks, then 40 mg every 2 weeks)
You will not qualify if you...
- Unable to provide written consent for study participation
- Pregnant or breastfeeding
- Presence of a stoma
- Presence of short bowel syndrome
- Previous treatment with an anti-TNF alpha inhibitor
- Use of other biologic or oral small molecule therapy within the last 12 weeks
- Current use of oral or intravenous steroids above specified doses
- Recent changes in immunomodulator medication within the past 8 weeks
- Use of oral antibiotics within the past 4 weeks
- Crohn's disease with major fistulising or symptomatic fibrotic stricturing
- Positive test for blood-borne viruses such as HIV or Hepatitis
- Untreated latent or active tuberculosis
- Currently enrolled in other studies involving investigational products or dietary interventions
- Food allergies preventing participation (e.g., cow's milk allergy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom, G31 2ER
Actively Recruiting
2
Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom
Actively Recruiting
3
Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
4
The New Victoria Hospital
Glasgow, United Kingdom, G42 9LF
Actively Recruiting
Research Team
A
Aleksandra Jatkowska, BSc (Hons)
CONTACT
B
Bernadette E White, MBio (Hons)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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