Microbial Dysbiosis in Rheumatoid Arthritis

NCT03802890 | Unknown

• 1 other identifier: QIB01/2018
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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. The microbiome will be characterised via shotgun metagenomic sequencing of microbial DNA present in stool samples taken during the participant's first 6 months of taking methotrexate.

Conditions

Rheumatoid Arthritis

Keywords

microbial dysbiosis; rheumatoid arthritis; dietary factors

Outcome Measures

Primary Outcomes (1)

• Change in DAS28-CRP score

  Disease Activity Score using 28 joints and C-reactive Protein

  0-6 months

Secondary Outcomes (5)

• Change in SDAI score

  0-6 months

• Concentration of CRP in blood

  0-6 months

• ESR value (blood)

  0-6 months

• Concentration of anti-CCP in blood

  0-6 months

• Concentration of RF in blood

  0-6 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Early rheumatoid arthritis commencing methotrexate monotherapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Action Arthritis: collaborator
• University of East Anglia: collaborator
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

* faecal samples * blood samples

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Simon Carding, Prof

  Quadram Institute Bioscience

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: February 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: July 30, 2021
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

GB (1)