Status:
UNKNOWN
Microbial Dysbiosis in Rheumatoid Arthritis
Lead Sponsor:
Quadram Institute Bioscience
Collaborating Sponsors:
Action Arthritis
University of East Anglia
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Brief Summary
The MyRA study will primarily investigate whether there are associations between the structure and function of the gut microbiome and response to methotrexate in early rheumatoid arthritis patients. T...
Detailed Description
Methotrexate is often the first drug of choice for patients with early rheumatoid arthritis (RA), but its efficacy is highly variable and it can lead to severe side effects. There are currently no rel...
Eligibility Criteria
Inclusion
- 18-65 years of age
- RA diagnosis based on ACR 2010 classification criteria with symptoms starting within the last 2 years
- Referred by GP to the Early Arthritis Clinic at the Norfolk and Norwich University Hospitals NHS trust
- Commencing methotrexate monotherapy for the first time
Exclusion
- Initially commencing combination therapy (prior to first stool sample) rather than methotrexate monotherapy i.e. MTX combined with another DMARD or prednisolone
- Commencement of MTX therapy prior to first stool sample or cessation of MTX therapy at any point during the study
- History of psoriasis
- Those currently suffering from, or have ever suffered from, any diagnosed gastrointestinal disease, gastrointestinal disorders including regular diarrhoea and constipation (excluding hiatus hernia unless symptomatic) and/or have undergone gastrointestinal surgery.
- Those regularly (3+ times/week) taking self-prescribed over the counter medications for digestive/gastrointestinal conditions
- Use of laxatives within 7 days prior to sampling unless these have been used on a regular basis (3+ times/week) for more than one month prior to the study and will continue to be used throughout the study period
- The use of over-the-counter medications or food/drinks containing pre and/or probiotics within 7 days prior to sampling, unless these have been used on a regular basis (3+ times/week) for more than one month prior to the study and will continue to be used throughout the study period
- Significant alteration of the participant's normal diet at any point during the study (e.g. adoption of the 5:2 fasting diet)
- Regular (3+ times/week) or recent (within 3 months) use of colonic irrigation or other bowel cleansing techniques
- Recently returned to the UK following a period abroad, and who have suffered gastric symptoms during the period abroad or on return to the UK. These will be assessed on an individual basis
- Currently taking or finished a course of antibiotics within the last 3 months
- Currently pregnant or lactating
- Living with or related to any member of the Study Team
- Those who have limited or no understanding of spoken and written English
Key Trial Info
Start Date :
February 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03802890
Start Date
February 1 2019
End Date
July 30 2021
Last Update
June 18 2020
Active Locations (1)
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1
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY