UnknownNot Applicable

Protocol for an Analytical Study With Microbiological, Phenotypic, Genotypic and Multiomics Techniques

Brazil120 participantsStarted 2021-08-01

Plain-language summary

The study aims to identify metabolites present in intervertebral discs colonized by C. acnes from patients with low back pain and degenerative disc disease, correlating them with their clinical, radiological and demographic profiles.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * low back pain lasting longer than 3 months; * MRI findings of degenerative lumbar discopathy (DDL) performed less than 6 months after inclusion in the study; * indication for open surgical treatment, with isolated microdiscectomy or associated with lumbar arthrodesis; * failure of conservative treatment for at least 6 weeks and/or progressive neurological deficit Exclusion Criteria: * History of open lumbar spine surgery at any stage of life; * presence of chemotherapy or pulse therapy with corticoids; * patients with immune deficiency; * patients undergoing previous intradiscal therapies (nucleotomy or discography); * patients undergoing previous endoscopic surgery; * patients with a history of previous spinal infection treated with antibiotics in the 6 months prior to inclusion in the study; * use of antibiotics in the 2 months prior to the surgical procedure

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of C. acnes on intervertebral disc

Timeframe: Up to 5 months

Trial details

NCT IDNCT05090553

SponsorGaffree & Guinle Universitary Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-01

Contact for this trial

Vinicius M da Rocha, MD

55 21 99700-7240 viniciusmagnodarocha@gmail.com

View on ClinicalTrials.gov More Back Pain, Low trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.