Spine Microbiome Study
Research type
Research Study
Full title
Does occult infection account for disc degeneration with type 1 Modic change\nin the lumbar spine?
IRAS ID
279780
Contact name
Reza Razavi
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Low back pain is the leading cause of disability globally, caused largely by intervertebral disc degeneration. In some cases, disc degeneration may be caused by changes to the vertebra of the spine known as Modic change. Inflammatory Modic change (type 1) may be caused by bacteria from elsewhere in the body reaching the vertebral endplate leading to damage, inflammation and disc degeneration. We will collect surgical samples and compare bacterial DNA from removed discs that were adjacent to vertebra with type 1 Modic change (cases) to removed discs adjacent to vertebra without Modic change (controls). We will investigate bacterial DNA origins identified in the spine by collecting urine, saliva, faeces, skin swab and blood samples. The project aims to identify bacteria(-um) responsible for Modic type 1 change.\nPatients undergoing spine surgery, discectomy or spine fusion are eligible and will be approached at surgical centres to discuss enrolling and consent. Consenting patients will be provided with stool collection kits and a researcher will collect saliva, urine, skin swabs and blood during routine preoperative appointments. Participants will also be asked to fill a questionnaire to ensure accurate interpretation of the bacterial results (questions regarding age, sex, body mass index, medication use, infection history, diet and stool information).\nThe project will run over 4 years. Years 1 and 2 will be allocated to patient recruitment and sample collection. Year 3 will see the samples being sent to the laboratories where they will be analysed for the bacterial genetic content using a process called 16S RNA gene analysis. Statistical testing will follow, along with writing up and dissemination during year 4.\n
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
20/YH/0284
Date of REC Opinion
9 Oct 2020
REC opinion
Further Information Favourable Opinion