Dietary n-3 PUFAs and the response to adalimumab in Crohn’s disease
Research type
Research Study
Full title
Investigating the effect of dietary polyunsaturated fatty acids and resolvins on the efficacy of adalimumab in Crohn’s disease.
IRAS ID
137342
Contact name
Andrew Hart
Contact email
Sponsor organisation
University of East Anglia
Research summary
Crohn’s disease (CD) is a swelling of any part of the wall of the gastrointestinal system. Patients experience periods of control and flare ups of their symptoms. Currently, there is no cure for CD, although antibody drugs which block tumour necrosis factor alpha (anti-TNFα) are an effective treatment. TNFα is a chemical that is raised in CD resulting in bowel swelling and the consequent symptoms. Unfortunately, for unknown reasons, these anti-TNFα drugs are ineffective in about half of patients. This proposed research aims to investigate whether particular diets increase the effectiveness of such anti-TNFα drugs in CD.
The existing limited research suggests that dietary n-3 polyunsaturated fatty acids (n-3 PUFAs), present in fish oils, may enhance the effectiveness of anti- TNFα drugs. N-3 PUFAs are converted in the body to chemicals, known as resolvins, that both dampen down and reverse harmful inflammation. Without resolvins derived from the diet, anti-TNFα drugs in CD may be less effective. However, there are no clinical studies in patients with CD which have investigated diet and drug effectiveness. This proposed observational study will measure if high intakes of dietary n-3 PUFAs, as measured in blood samples, are linked with greater responses to the anti-TNFα drugs over 12 weeks in 154 CD patients treated in 3 UK teaching hospitals. Treatment responses will be recorded using short symptom questionnaires Specialised laboratory techniques, (mass spectrometry) will measure if there are differences in the amounts of resolvins before and after treatment, and also between drug responders and non-responders. This initial research will provide information to support and inform the development of a future clinical trial assessing if high dietary n-3 PUFA intakes, given with anti-TNFα, increase drug effectivness. Such a combined drug/diet approach may improve the health and quality of life of patients with CD.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
13/EE/0368
Date of REC Opinion
18 Nov 2013
REC opinion
Favourable Opinion