Mi-PART
Research type
Research Study
Full title
Microbiome in Psoriatic ARThritis (Mi-PART)
IRAS ID
217745
Contact name
Jonas Mmesi
Contact email
Sponsor organisation
Joint Research Compliance Office.
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Summary of Research
Psoriatic Arthritis is a joint problem (arthritis) that often occurs with a skin condition called psoriasis. Psoriasis is a common skin problem that causes red scaly patches on the body, and it is an on-going (chronic) inflammatory condition. Around 30 percent of those with psoriasis will develop arthritis with the skin condition. In most cases, psoriasis comes before the arthritis. Therefore the presence of skin psoriasis is a major risk factor for the development of an inflammatory form of arthritis. Additional risk factors included obesity, smoking, the presence of nail psoriasis and possibly the severity and distribution of psoriasis, all factors that may be linked to the host’s microbiome.
Ankylosing Spondylitis is a long-term type of arthritis that mainly affects the joints of the spine (back). It causes inflammation that leads to pain, stiffness with limited back mobility and tiredness. It affects 200,000 people in the United Kingdom and one female for every three males. Although linked to a particular gene found in up to 9 out of 10 patients with ankylosing spondylitis, the cause is also still unknown.
The purpose of this study is to identify, group into classes and mark the differences in gut microorganisms (microbiome) found in patients with psoriatic arthritis and ankylosing spondylitis, and compared to participants without these conditions and consider themselves "health".
We are looking to recruit 200 participants in total to this study. This includes 100 people with psoriatic arthritis, 50 people with Ankylosing spondylitis and 50 people without both conditions.
Eligible participants at screening visit will be allocated into Group A (50 PsA) to attend four visits at screening, week-0, week-12 and week-24 respectively. Group B (50 PsA), Group C (50 AS), Group D (HC) to attend screening and week- 0 (baseline) only.
Schedule of events will involve data collection of medical and medication history, demographics, physical examination, diet and lifestyle questionnaires, food diary, vital signs (BP,pulse and) weight, height (BMI), examination of patient joints and skin, disease activity scores, patient reported outcomes by health and quality of life questionnaires. Routine blood tests, study specific blood, DNA assessment, urine and stool sample collection.Summary of Results
NEW LINKS BETWEEN PSORIATIC ARTHRITIS AND THE GUT MICROBIOME SUGGEST A STRONGER ROLE OF THE GUT-JOINT AXIS Jesus Miguens Blanco, Nathan Danckert, Zhigang Liu, Laura Martinez Gili, Ben Mullish, Julie McDonald, Mark Lindsay, Raj Sengupta, Neil McHugh, Sonya Abraham, Julian Marchesi.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0175
Date of REC Opinion
8 May 2017
REC opinion
Favourable Opinion