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Seroprevalence of Brucella Antibodies in High-Risk Patients With Low Back Pain: A Case-Control Study

Seroprevalence of Brucella Antibodies in High-Risk Patients With Low Back Pain: A Case-Control Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07112677
Enrollment
100
Registered
2025-08-08
Start date
2024-02-01
Completion date
2025-02-28
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brucellosis, Low Back Pain

Keywords

brucella antibodies, low back pain

Brief 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. 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

Interventions

DIAGNOSTIC_TESTBrucella 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.

Sponsors

Elham Ahmed Hassan
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Brucella Antibodies in High-Risk Patients with Low Back PainFebruary 2024 to February 2025The 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026