BrucellosisNCT07112677
Seroprevalence of Brucella Antibodies in High-Risk Patients With Low Back Pain: A Case-Control Study
An observational study of Brucellosis and Low Back Pain, run by Elham Ahmed Hassan at 2 sites in Egypt.
Trial summary
The goal of this observational case-control study is to assess the presence of Brucella antibodies in patients with low back pain who are at high risk for brucellosis exposure, such as those with animal contact or consumption of unpasteurized dairy products. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brucellosis, Low Back Pain
- What is being tested?
- Brucella Antibody Testing (ELISA)
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Feb 2024to 28 Feb 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with high risk of Brucella exposure (e.g., animal contact or consumption of unpasteurized dairy products), including patients presenting with non-specific low back pain and healthy controls without back pain. Participants were recruited from outpatient clinics and inpatient wards at Assiut University Hospital.
Who may be able to join
- Adults of any sex at high risk of Brucella exposure (e.g., contact with livestock or consumption of unpasteurized dairy products)
- Patients presenting with non-specific low back pain
- Willing and able to provide informed consen
Who cannot join
- Evidence of tuberculosis (Pott's disease)
- Evidence of septic spondylitis
- Known metastatic bone lesions
- Known degenerative or autoimmune rheumatologic spinal diseases
- History of prior spinal surgery or trauma
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Assiut University Hospital
Asyut, 71515
Assiut University
Asyut, 71515
About this study
The goal of this observational case-control study is to assess the presence of Brucella antibodies in patients with low back pain who are at high risk for brucellosis exposure, such as those with animal contact or consumption of unpasteurized dairy products. The main question it aims to answer is:
Is there a significant association between Brucella seropositivity and low back pain in high-risk individuals?
Read more
Researchers will compare patients with low back pain to age- and sex-matched healthy controls without back pain but with similar exposure risks, to see if Brucella antibodies are more frequent in the patient group.
Participants will:
Undergo a detailed clinical history and physical examination
Provide blood samples for serological testing using ELISA for Brucella IgG/IgM/IgA
Be evaluated for other symptoms such as fever, fatigue, and joint pain
- Conditions
- Brucellosis, Low Back Pain
- Being tested
- Brucella Antibody Testing (ELISA)
- Keywords
- brucella antibodies, low back pain
- Medical subject headings
- Brucellosis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brucella Antibody Testing (ELISA)Diagnostic test
Serological testing for Brucella antibodies using the SERION ELISA classic Brucella IgG/IgM/IgA kit (Institut Virion\Serion GmbH, Würzburg, Germany). The test detects Brucella-specific IgG, IgM, and IgA antibodies in serum samples to assess current or past exposure. All samples were processed and interpreted according to the manufacturer's instructions. This diagnostic intervention was used for both the low back pain group and the control group.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Patients): Low Back Pain Group, Group 2 (Controls): Control Group | Not described Receives: Diagnostic Test: Brucella Antibody Testing (ELISA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Brucella Antibodies in High-Risk Patients with Low Back Pain
The presence of Brucella antibodies (IgG, IgM, and IgA) in serum was assessed using the SERION ELISA classic Brucella kit. A positive result indicates prior or current exposure to Brucella species. The outcome compares the proportion of seropositive individuals between patients with low back pain and matched controls.
Measured: February 2024 to February 2025
Prevalence of Brucella Antibodies in High-Risk Patients with Low Back Pain
The presence of Brucella antibodies (IgG, IgM, and IgA) in serum was assessed using the SERION ELISA classic Brucella kit. A positive result indicates prior or current exposure to Brucella species. The outcome compares the proportion of seropositive individuals between patients with low back pain and matched controls.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Feb 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BrucellosisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elham Ahmed Hassan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elham Ahmed Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112677
- Sponsor's protocol ID
- AUN-BRU-LBP-2024
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not have specific consent from participants to share individual-level data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of Brucella Antibodies in High-Risk Patients With Low Back Pain: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07112677
- Acronym / sponsor ID
- AUN-BRU-LBP-2024
- Conditions
- Brucellosis, Low Back Pain
- Keywords
- brucella antibodies, low back pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Elham Ahmed HassanUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 8 Aug 2025 (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 goal of this observational case-control study is to assess the presence of Brucella antibodies in patients with low back pain who are at high risk for brucellosis exposure, such as those with animal contact or consumption of unpasteurized dairy products. The main question it aims to answer is:
Is there a significant association between Brucella seropositivity and low back pain in high-risk individuals?
Researchers will compare patients with low back pain to age- and sex-matched healthy controls without back pain but with similar exposure risks, to see if Brucella antibodies are more frequent in the patient group.
Participants will:
Undergo a detailed clinical history and physical examination
Provide blood samples for serological testing using ELISA for Brucella IgG/IgM/IgA
Be evaluated for other symptoms such as fever, fatigue, and joint pain
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Patients): Low Back Pain Group, Group 2 (Controls): Control Group | – | Diagnostic Test: Brucella Antibody Testing (ELISA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with high risk of Brucella exposure (e.g., animal contact or consumption of unpasteurized dairy products), including patients presenting with non-specific low back pain and healthy controls without back pain. Participants were recruited from outpatient clinics and inpatient wards at Assiut University Hospital.
Key inclusion criteria (3 listed)
- Adults of any sex at high risk of Brucella exposure (e.g., contact with livestock or consumption of unpasteurized dairy products)
- Patients presenting with non-specific low back pain
- Willing and able to provide informed consen
Key exclusion criteria (5 listed)
- Evidence of tuberculosis (Pott's disease)
- Evidence of septic spondylitis
- Known metastatic bone lesions
- Known degenerative or autoimmune rheumatologic spinal diseases
- History of prior spinal surgery or trauma
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 |
|---|---|---|
| Brucella Antibody Testing (ELISA)Serological testing for Brucella antibodies using the SERION ELISA classic Brucella IgG/IgM/IgA kit (Institut Virion\Serion GmbH, Würzburg, Germany). The test detects Brucella-specific IgG, IgM, and IgA antibodies in serum samples to assess current or past exposure. All samples were processed and interpreted according to the manufacturer's instructions. This diagnostic intervention was used for both the low back pain group and the control group. | Diagnostic test | Group 1 (Patients): Low Back Pain Group, Group 2 (Controls): Control Group |
Primary outcome
Prevalence of Brucella Antibodies in High-Risk Patients with Low Back Pain
Time frame: February 2024 to February 2025
The presence of Brucella antibodies (IgG, IgM, and IgA) in serum was assessed using the SERION ELISA classic Brucella kit. A positive result indicates prior or current exposure to Brucella species. The outcome compares the proportion of seropositive individuals between patients with low back pain and matched controls.
Prevalence of Brucella Antibodies in High-Risk Patients with Low Back Pain
Time frame: At enrollment
The presence of Brucella antibodies (IgG, IgM, and IgA) in serum was assessed using the SERION ELISA classic Brucella kit. A positive result indicates prior or current exposure to Brucella species. The outcome compares the proportion of seropositive individuals between patients with low back pain and matched controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No. I do not have specific consent from participants to share individual-level data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brucellosis and Low Back Pain, run by Elham Ahmed Hassan at 2 sites in Egypt.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Brucella Antibodies in High-Risk Patients with Low Back Pain (time frame: February 2024 to February 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2025.