Status:
RECRUITING
Biologics and Partial Enteral Nutrition Study
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborating Sponsors:
University of Glasgow
Conditions:
Crohn Disease
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
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 l...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04859088
Start Date
September 20 2021
End Date
September 1 2026
Last Update
November 30 2021
Active Locations (4)
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1
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom, G31 2ER
2
Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom
3
Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN
4
The New Victoria Hospital
Glasgow, United Kingdom, G42 9LF