Back Pain, LowNCT05090553
Protocol for an Analytical Study With Microbiological, Phenotypic, Genotypic and Multiomics Techniques
A study testing Lumbar Spinal Fusion Surgery, Bacterial culture and Phenotypic and genotypic characterization in people with Back Pain, Low and Degenerative Disc Disease, run by Gaffree & Guinle Universitary Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain, Low, Degenerative Disc Disease
- What is being tested?
- Lumbar Spinal Fusion Surgery, Bacterial culture and Phenotypic and genotypic characterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Universitário Gaffrée e Guinle
Rio de Janeiro, 20270-004
Vinicius M da Rocha, MD, 55 21 99700-7240, viniciusmagnodarocha@gmail.com
About this study
Official title: Cutibacterium Acnes Colonization on Intervertebral Discs of Patients With Low Back Pain: Protocol for an Analytical Study With Microbiological, Phenotypic, Genotypic and Multiomics Techniques
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.
- Conditions
- Back Pain, Low, Degenerative Disc Disease
- Being tested
- Lumbar Spinal Fusion Surgery, Bacterial culture, Phenotypic and genotypic characterization, Multiomics analysis
- Medical subject headings
- Low Back Pain, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Spinal Fusion SurgeryProcedure or surgery
During surgery will be collected five disc fragments and five fragments of muscle-ligament tissue adjacent to the collected disc.
Bacterial cultureBiological
Samples will be seeded on blood agar and anaerobic blood agar plates. After sowing in solid media, the swab will be inoculated in thioglycolate medium, where it will remain for 14 days
Phenotypic and genotypic characterizationGenetic
The phenotypic identification of the species will be carried out through mass spectrometry, with the MALDI-TOF equipment.
PCR analyzes performed in two phases, the first to confirm the presence of bacteria (target and non-target) using primers capable of amplifying eubacteria ribosomal deoxyribonucleic acid (rDNA) 16s and the second directed to confirm C. acnes through specific rDNA 16s primers.
Multiomics analysisGenetic
Whole Genome Sequencing, proteomics and metabolomics analysis
| Study group | Role | What they receive |
|---|---|---|
| surgical treatment | Active comparator | Lumbar Spinal Fusion Surgery Receives: Procedure: Lumbar Spinal Fusion Surgery |
| Bacterial culture | Experimental | Cutibacterium acnes culture in two different atmosphere:
* Carbon dioxide (CO2) from 5% up to 10%
* CO2 10%, H2 10% and N2 80% Receives: Biological: Bacterial culture |
| Phenotypic and genotypic characterization | Experimental | Mass spectrometry and (Polimerase Chain Reaction) PCR Receives: Genetic: Phenotypic and genotypic characterization |
| Multiomics analysis | Experimental | * Genome sequencing
* Proteomics
* Metabolomics Receives: Genetic: Multiomics analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of C. acnes on intervertebral disc
Incidence of C. acnes on intervertebral disc in patients with chronic low back pain and DDL.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Aug 2021
- Primary completion1 Aug 2022
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back Pain, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaffree & Guinle Universitary Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Vinicius Magno da Rocha, Gaffree & Guinle Universitary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090553
- Sponsor's protocol ID
- VMRDocProtocol_2021
- Status last verified
- Aug 2022
- First submitted
- 28 Sep 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Magno da Rocha V, Lima COGX, Ferreira EO, de Farias GC, Nogueira FCS, Martha Antunes LC, Cassiano KM, Fiorelli RKA. Colonization of intervertebral discs by Cutibacterium acnes in patients with low back pain: Protocol for an analytical study with microbiological, phenotypic, genotypic, and multiomic techniques. PLoS One. 2023 Feb 27;18(2):e0271773. doi: 10.1371/journal.pone.0271773. eCollection 2023.
PubMed 36848344
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutibacterium Acnes Colonization on Intervertebral Discs of Patients With Low Back Pain: Protocol for an Analytical Study With Microbiological, Phenotypic, Genotypic and Multiomics Techniques
- ClinicalTrials.gov ID
- NCT05090553
- Acronym / sponsor ID
- VMRDocProtocol_2021
- Conditions
- Back Pain, Low, Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Gaffree & Guinle Universitary HospitalUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| surgical treatment | Active comparator | Procedure: Lumbar Spinal Fusion SurgeryLumbar Spinal Fusion Surgery |
| Bacterial culture | Experimental | Biological: Bacterial cultureCutibacterium acnes culture in two different atmosphere: * Carbon dioxide (CO2) from 5% up to 10% * CO2 10%, H2 10% and N2 80% |
| Phenotypic and genotypic characterization | Experimental | Genetic: Phenotypic and genotypic characterizationMass spectrometry and (Polimerase Chain Reaction) PCR |
| Multiomics analysis | Experimental | Genetic: Multiomics analysis* Genome sequencing * Proteomics * Metabolomics |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar Spinal Fusion SurgeryDuring surgery will be collected five disc fragments and five fragments of muscle-ligament tissue adjacent to the collected disc. | Procedure or surgery | surgical treatment |
| Bacterial cultureSamples will be seeded on blood agar and anaerobic blood agar plates. After sowing in solid media, the swab will be inoculated in thioglycolate medium, where it will remain for 14 days | Biological | Bacterial culture |
| Phenotypic and genotypic characterizationThe phenotypic identification of the species will be carried out through mass spectrometry, with the MALDI-TOF equipment. PCR analyzes performed in two phases, the first to confirm the presence of bacteria (target and non-target) using primers capable of amplifying eubacteria ribosomal deoxyribonucleic acid (rDNA) 16s and the second directed to confirm C. acnes through specific rDNA 16s primers. | Genetic | Phenotypic and genotypic characterization |
| Multiomics analysisWhole Genome Sequencing, proteomics and metabolomics analysis | Genetic | Multiomics analysis |
Primary outcome
Incidence of C. acnes on intervertebral disc
Time frame: Up to 5 months
Incidence of C. acnes on intervertebral disc in patients with chronic low back pain and DDL.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Derived from this study: PubMed 36848344Magno da Rocha V, Lima COGX, Ferreira EO, de Farias GC, Nogueira FCS, Martha Antunes LC, Cassiano KM, Fiorelli RKA. Colonization of intervertebral discs by Cutibacterium acnes in patients with low back pain: Protocol for an analytical study with microbiological, phenotypic, genotypic, and multiomic techniques. PLoS One. 2023 Feb 27;18(2):e0271773. doi: 10.1371/journal.pone.0271773. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Spinal Fusion Surgery, Bacterial culture and Phenotypic and genotypic characterization in people with Back Pain, Low and Degenerative Disc Disease, run by Gaffree & Guinle Universitary Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vinicius M da Rocha, MD (55 21 99700-7240, viniciusmagnodarocha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of C. acnes on intervertebral disc (time frame: Up to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05090553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.