Cutibacterium acnes and degenerative lumbar disc disease after microdiscectomy
The Role of Cutibacterium Acnes in the Development of Degenerative Lumbar Intervertebral Disc Disease and the Clinical Effect of Microdiscectomy
This project will try to see if the bacterium Cutibacterium acnes is linked to degenerative lumbar disc disease in adults who had microdiscectomy for lumbar disc herniation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Masaryk University Academic / other |
| Locations | 1 site (Brno) |
| Trial ID | NCT07085247 on ClinicalTrials.gov |
What this trial studies
The project combines a retrospective analysis of an existing database of roughly 1,200 adults treated for symptomatic lumbar disc herniation at St. Anne's University Hospital Brno, of which at least 400 have complete epidemiologic, MRI, microbiological, and clinical records. The prospective arm will enroll new patients scheduled for microdiscectomy, collect preoperative clinical data, obtain perioperative disc tissue samples, perform microbiological testing for Cutibacterium acnes, and conduct postoperative follow-up visits. Microbiological findings will be correlated with imaging and standardized clinical outcomes and analyzed with appropriate data management and statistical methods. Comparisons between retrospective and prospective cohorts will be used to clarify whether the bacterium is associated with degenerative lumbar intervertebral disc disease.
Who should consider this trial
Good fit: Adults (≥18 years) with MRI-confirmed lumbar disc protrusion/herniation or sequestration, matching clinical exam findings, and who are scheduled for microdiscectomy without recent antibiotic or corticosteroid use are ideal candidates.
Not a fit: Patients without MRI-confirmed herniation, those with non-surgical causes of low back pain, immunocompromised individuals, recent antibiotic/corticosteroid users, or those with inflammatory/rheumatologic spine disease are unlikely to receive direct benefit from participation.
Why it matters
Potential benefit: If successful, this work could show a bacterial contribution to disc degeneration and point toward new prevention or treatment approaches that reduce back pain and improve surgical outcomes.
How similar studies have performed: Previous studies have suggested a possible link between low-virulence Cutibacterium acnes in disc tissue and disc degeneration, but results have been mixed and the relationship remains controversial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * minimum age of 18 years * MRI of the lumbosacral spine performed one month ± 2weeks before surgery showing a disc protrusion, herniation, or free nucleus pulposus sequestration * matching physical examination findings including positive straight leg raise test, dermatomal sensory deficits, myotome motor deficits, and diminished deep tendon reflexes. Exclusion Criteria: * antibiotics or corticosteroid use the month before surgery * ongoing bacterial or viral infection * immunocompromised patient * trauma * undefined radiological mass * inflammatory arthritis * other rheumatologic diseases.
Where this trial is running
Brno
- St. Anne´s University Hospital Brno — Brno, Czechia (Recruiting)
Study contacts
- Study coordinator: Peter Solár, MUDr., Ph.D.
- Email: peter.solar@fnusa.cz
- Phone: +420 770 638 756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.